1) A study examined the effects of zoledronic acid administered every 18 months versus placebo on fracture risk in osteopenic postmenopausal women over 6 years.
2) Preliminary results show that among 2000 women aged 71 with osteopenia, zoledronic acid significantly reduced the risk of clinical fractures compared to placebo.
3) The study provides evidence that antiresorptive treatment administered every 18 months can reduce fracture risk in osteopenic postmenopausal women.
2020 OA Vision: Emerging Therapeutics on the OA landscapeOARSI
Philip Conaghan MBBS PhD FRACP FRCP
Director, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds
Deputy Director, NIHR Leeds Biomedical Research Centre
2020 OA Vision: Emerging Therapeutics on the OA landscapeOARSI
Philip Conaghan MBBS PhD FRACP FRCP
Director, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds
Deputy Director, NIHR Leeds Biomedical Research Centre
Dr Zoe Paskins's presentation from Osteoporosis 2016: Risk of fragility fracture over 10 years across eight inflammatory conditions: A UK population study.
Find out more at: https://nos.org.uk/conference
Prof. Richard Eastell's presentation from Osteoporosis 2016: Patients receiving bisphosphonates should take holidays from treatment. The case for holidays.
Find out more at: https://nos.org.uk/conference
Dr Steve Cummings presentation from Osteoporosis 2016: Patients receiving bisphosphonates should not take holidays from treatment.
Find out more at: https://nos.org.uk/conference
Vertebral Fracture Identification presented by Dr Andrew Pearson, Consultant Radiologist, Borders Hospital, Melrose at the fracture liaison service champions' summit 2016. #flschampions
Prof. Richard Keen's presentation from Osteoporosis 2016: Teaching old dogs new tricks? Combination therapy in osteoporosis.
Find out more at: https://nos.org.uk/conference
Dr Zoe Paskins's presentation from Osteoporosis 2016: Risk of fragility fracture over 10 years across eight inflammatory conditions: A UK population study.
Find out more at: https://nos.org.uk/conference
Prof. Richard Eastell's presentation from Osteoporosis 2016: Patients receiving bisphosphonates should take holidays from treatment. The case for holidays.
Find out more at: https://nos.org.uk/conference
Dr Steve Cummings presentation from Osteoporosis 2016: Patients receiving bisphosphonates should not take holidays from treatment.
Find out more at: https://nos.org.uk/conference
Vertebral Fracture Identification presented by Dr Andrew Pearson, Consultant Radiologist, Borders Hospital, Melrose at the fracture liaison service champions' summit 2016. #flschampions
Prof. Richard Keen's presentation from Osteoporosis 2016: Teaching old dogs new tricks? Combination therapy in osteoporosis.
Find out more at: https://nos.org.uk/conference
Update on the 18th International Conference on Co-morbidities and Adverse Drug Reactions in HIV
Daniel Lee, M.D.
January 20th, 2017
UCSD HIV & Global Health Rounds
IWO Meeting 1 November 2023 - Stopping with Denosumab and Romosozumab, basic mechanisms and clinical aspects door Prof. dr. S. Ferrari, Geneva, Switzerland. (Engelstalige lezing)
IWO Meeting 16 November 2022 - ASBMR young talent: Silvia Storoni (Amsterdam): Prevalence and Hospital Admissions in Patients With Osteogenesis Imperfecta in The Netherlands: A Nationwide Registry Study
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
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Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
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Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
IWO bijeenkomst - 14 november - J.P. van den Bergh
1. Joop van den Bergh
ASBMR 2018 highlights
Adapted from:
ASBMR 2018 slideset
2. Relations that could be relevant for the
meeting
Company name
Research funds
Speaker board / consultancy / travel
Stakeholder
Stock or other…
Amgen, Eli Lilly, Novo Nordisk
Amgen, Eli Lilly, UCB, Sanofi
• -
• -
Disclosure of speaker’s interests
3. Montreal
The ASBMR Program for 2018
• Meet The Professors (12 clinical,10 basic translational)
• Working Groups (5)
• Oral abstracts 157 (12% of total 1304, = 2017)
• Late-breaking abstracts 118 (+28% over 2017)
• 2018: Total (not including late breaking abstracts) = 1304 (+5.6%)
• 2 Dutch Young investigator awards
5. #1023: Abrahamsen, Skjodt, Vesteragaard. Hip fracture rates and time
trends in use of anti-osteoporosis medications in Denmark for the period
2005-2015
Background: The “treatment gap” has been based upon declining
bisphosphonate use in the outpatient setting.
Question: Would the treatment gap be different if ALL anti-osteoporotic
meds were compared with hip fracture rates over the same period?
Methods: National data base: hip Fxs and total use of all medicines. # of Fx
prevented due to drugs assumed to be 0.3 hip Fxs per 100 person years
(from FIT without Fx).
6. #1023: Abrahamsen, Skjodt, Vesteragaard. Hip fracture rates and time trends
in use of anti-osteoporosis medications in Denmark for the period 2005-2015
Hip fractures sustained
Hip fractures prevented‘14
Results: Hip Fxs declined
by 30%; med use peaked in
‘14. Only 10% of the hip Fx
decline could be attributed to
medication use.
7. 0905: Treatments for Osteoporosis Do Not Reduce Overall Mortality
Steven Cummings, Li-Yung Lui, Douglas C. Bauer, Dennis M. Black
• Included placebo-controlled trials with at least 50 participants in the placebo
group and at least one death
• Trials with secondary causes, such as corticosteroid use, were excluded.
• Estrogen therapy and strontium were not included
• With and without Selective estrogen receptor modulators (SERMs) and
tibolone: no dfifference outcome
• If there was more than one type of treatment, each treatment arm was
compared to the placebo group.
10. #1025: Thomas Merlijn*, Swart, Netelenbos, Elders. Screening of High
Fracture Risk in Primary Care Not Effective
Background: Identifying women for treatment after a fracture event is reactive
Question: Can a proactive screening program to identify women who meet criteria
for treatment reduce fractures?
Methods: Women (65-90) with at least 1 CRF (previous fracture, parental hip
fracture, low body weight, secondary causes for osteoporosis) were either evaluated
(BMD, VFA, and FRAX) or assigned to ‘usual care.’
Rx given if indicated. Follow up: 3.7 yrs.
Results: Active screening and subsequent Rx had no effect on time to first Fx, nor
first hip Fx.
*Young investigator award
11. #1231 Late breaking: Thomas Merlijn, Swart, Netelenbos, Elders.
A systematic review and meta-analysis of ROSE, SCOOP and Salt (SOS) studies
All three studies:
• primary care population
• women (mean age 70-75),
• high fracture risk
• Based on questionnaire
followed by BMD in the
women with increased
risk
• Small differences in risk
selection and treatment
thresholds, but all studies used
FRAX in risk selection or in
treatment thresholds.
• In all studies there was dilution:
in the intervention group 13-25%
had a treatment indication and
11-17% started anti-osteoporotic
drugs.
13. Frans Heyer. The Effect of Vitamin D3 Supplementation on Distal Radius Fracture
Healing: A Randomized Controlled HR-pQCT Trial
Background:
Question: To asses the effect of vitamin D3 (cholecalciferol) supplementation on HR-
pQCT/μFEA-based outcome measures in distal radius fracture healing.
Methods: 3 month follow-up after fracture
• Control group (no supplementation)
• Low-dose group: 30.000 IU cholecalciferol/6 weeks (equivalent to 700 IU/day)
• High-dose group: 75.000 IU cholecalciferol/6 weeks (equivalent to 1800 IU/day)
14. Frans Heyer. The Effect of Vitamin D3 Supplementation on Distal Radius Fracture
Healing: A Randomized Controlled HR-pQCT Trial
• 700 IU/day does not accelerate or enhance fracture healing
• 1800 IU/day may be detrimental in restoring bone stiffness by increasing
bone resorption during the first 12 weeks of fracture healing
16. #1146: Leslie, Morin, Lix, McCloskey, Johansson, Harvey, Kanis. Fracture
Risk Assessment in Women with Breast Cancer Initiating Aromatase Inhibitor
Therapy
Background: Aromatase Inhibitor Rx for breast cancer is reported to be
associated with bone loss and increased fracture risk.
Question: Can FRAX be used to predict fracture risk in a population of women
> 40?
Methods:
• Breast cancer with >12 months of AI use (n=1775)
• Breast cancer without AI use (n=1016)
• No breast cancer (n=34,205)
Manitoba
17. CumulativeFractureIncidence
With competing mortality risk. AI use as “secondary osteoporosis”
Major osteoporotic fractures, log-rank p=0.148
Years
0 2 4 6 8 10
Cumulativeincidencefraction
0.00
0.05
0.10
0.15
0.20
General population
Breast cancer, aromatase inhibitor users
Breast cancer, aromatase inhibitor non-users
AI use
Top curves;
no AI use or
no cancer
#1146: Leslie, Morin, Lix, McCloskey, Johansson, Harvey, Kanis. Fracture
Risk Assessment in Women with Breast Cancer Initiating Aromatase Inhibitor
(AI)Therapy
Results:
Adjusted for FRAX with BMD
18. #1146: Leslie, Morin, Lix, McCloskey, Johansson, Harvey, Kanis. Fracture Risk
Assessment in Women with Breast Cancer Initiating Aromatase Inhibitor
(AI)Therapy
Conclusion: The data challenge the view that women initiating AI
Rx are at high fracture risk.
Comments:
• The conclusion may be based upon differences at baseline in
that AI users had higher BMI, higher BMD, lower osteoporosis
prevalence, and fewer fractures.
• There is no mention of whether AI users were treated
prophylactically with anti-osteoporosis medications.
19. #1143: Wallander, Axelsson, Lundh, Lorentzon. Patients with prostate cancer
(PC) and androgen deprivation therapy (ADT) have increased risk of fractures.
Background: ADT in men with PC is associated with increased risk of fractures. Most
studies, however, are small.
Question: Can a large database confirm this impression?
Methods: Swedish registry of 179,744 men (age 79) with PC and ADT (6954) or
without ADT (13128). Follow up: 270,300 patient years.
Results:
ADT use: greater risk of any Fx, hip Fx, and MOF.
PC without ADT use: no increase.
Conclusion: In this high risk group therapeutic intervention to prevent fractures on ADT
therapy is appropriate
With PC
+ ADT
20. #1143: Wallander, Axelsson, Lundh, Lorentzon. Patients with prostate cancer
(PC) and androgen deprivation therapy (ADT) have increased risk of fractures.
With PC
+ ADT
Time to hipfracture Time to major osteoporootic fracture
Osteoporos Int 2018 online 15-10-18
22. The Greater the Number of Prevalent Vertebral Fractures
(VFs),the Greater the Risk of Future VFs
14
12
10
8
6
4
0
2
IncidenceofNewVFat1Year(%)
0 1 ≥ 2≥ 1
Number of VFs at Baseline
Women with an
incident VF
had a 19% risk of
new VF within 1
year
Lindsay R, et al JAMA. 2001;285(3):320-323.
One year data in 2725 women randomized to placebo
23. #1112: Schousboe, Lix, Morin, Bryanton, Alhrbi, Leslie. Prevalent Vertebral
Fracture Identified on Densitometric Images Predict Incident Fractures in
Routine Clinical Practice.
Background: The predictive value of VFA in clinical practice has not been
established.
Design: Manitoba BMD database (‘10- ); Definite VFs identified in 15.8% of 9972
men and women (age 76). Incident fxs identified from administrative claims database
over 2.8 yrs.
24.
25. #1026: Schousboe, Lix, Morin, Derkatch, Bryanton, Alhrbi, Leslie. Identification
of Prevalent Vertebral Fracture Increases Utilization of Pharmacologic Fracture
Prevention Therapy
Conclusion: Even among those whose
fracture risk is high (either by T-score or
prevalent vert Fx), when a fracture is
documented by VFA, use of
osteoporosis medication increases
(OR 2.37 after adjustments for other
fracture risk assessments.)
Proportion treated
VFA+
VFA-
0
0.1
0.2
0.3
0.4
0.5
0.6
0 90 180 270 360
Cumulativeproportiontreated
Days after VFA
VFA
VFA +
VFA-
Proportion treated
27. #1058: Bauer, Vittinghoff, Black, Bouxsein, Cauley, de Papp, Grauer, Khosla, Mitlak,
McCulloch, Eastell. Change in Bone Turnover as a Surrogate Marker for Fracture
Outcome
#1070: Black, Vittinghoff, Eastell, Bauer, Lui, Palermo, McCulloch, Cauley, Khosla,
Marin, de Papp, Grauer, Bouxsein. Change in BMD as a Surrogate for Fracture Risk
Reduction in Osteoporosis Trials.
Background: FNIH Bone Quality Project seeks to identify a surrogate that can be used
in place of fracture in future clinical trials.
Questions: Are treatment-related changes in bone turnover markers (BTMs) and/or
bone mineral density (BMD) by DXA attractive candidates?
Design: A “mother-of-all” data collection studies! Combined and pooled data from 14
antiresorptive (BTMs) and 25 antiresorptive and anabolic (BMD) RCTs: > 100,000
subjects
28. #1058: Change in Bone
Turnover as a Surrogate
Marker for Fracture
Outcome (shaded, P
<0.05)
#1070: Change in BMD
as a Surrogate for
Fracture Risk Reduction
in Osteoporosis Trials.
(for all, P < 0.05)
Percent of Treatment Effect
Bone ALP PINP sCTX
Vertebral
(13 trials)
127% (86, 167%) 72% (29, 115%) 65% (32, 98%)
Non-vert
(15 trials)
117% (24, 209%) 130% (29, 231%) 87% (13,161%)
Hip(15 trials) 71% (-37, 178%) 150% (6, 294%) 27%(-70, 124%)
29. #1058: Change in Bone Turnover as a Surrogate Marker for Fracture Outcome
#1070: Change in BMD as a Surrogate for Fracture Risk Reduction in
Osteoporosis Trials.
Conclusions and Comment:
• Proof of Concept
• Analytical and statistical challenges
• Both BMD and BTMs (BMD>BTMs) explain a substantial percentage of treatment
effect for Vert and Non-vert (BMD and BTMS) and for Hip (BMD) fractures
• What is the clinical applicability to an individual patient, given that the study
“required” over 100,000 individuals to demonstrate these relationships?
31. #1074: Cosman, Lewiecki, Ebeling, Hesse, Napoli, Crittenden, Rojeski, Yang,
Libanati, Ferrari. T-score as an Indicator of Fracture Risk on Therapy.
Evidence from the Romosozumab v Alendronate Treatment in the ARCH Trial.
Question: Does improvement in T-score result in lower
fracture risk; does it depend upon the treatment received or
the T-score achieved?
Design: ARCH: 12 months 12 months
Alendronate
(n=2047)
Romosozumab
(n=2048)
Alendronate
Alendronate
32. #1074: Cosman, Lewiecki, Ebeling, Hesse, Napoli, Crittenden, Rojeski, Yang,
Libanati, Ferrari. T-score as an Indicator of Fracture Risk on Therapy.
Evidence from the Romosozumab v Alendronate Treatment in the ARCH Trial.
Results: TH T-score achieved after year
two correlated with the non-vert Fx rate
in the open label period, independent of
the drug.
Improvement in T-score
Romo (+0.31) ALN (+0.15)
Romo arm was associated with the
greater reduction in non-vert Fx rate.
Conclusion: Support for the treatment
to target concept.
Expected1-YearNonvertebralFracture
IncidenceinOpen-LabelPeriod(%)
Relationship was independent of treatment, age
strata, BMD, and severity of fracture at baseline
Nonvertebral Fracture
33. #1073: Leder, Lee, David, Eastell, Tsai. Rapid and Large BMD Increases in PM Women
Treated with Combined High-Dose teriparatide and Denosumab.
#1059: Tsai, Yuan, David, Lee, Bouxsein, Leder. Effect of Denosumab and High-Dose
Teriparatide on Peripheral Bone Mineral Density and Microarchitecture.
Background: DATA study: Combined Teriparatide and Dmab gives greater
increases in BMD and improved microstructure in comparison to either
drug alone. BTMs are compatible with a wider anabolic window.
Questions: Can a higher dose teriparatide (40 ug ) lead to an even wider
anabolic window than the 20 ug dose?
Design: 69 PM women, 15 months. Teriparatide 20 vs 40 ug given from
T=0 to nine months: Denosumab 60 mg SC in both groups at months
three, nine, and 15.
34. #1073: Leder et al Rapid and Large
BMD Increases in PM Women Treated
with Combined High-Dose teriparatide
and Denosumab
• Results: Higher dose of teriparatide
gives greater increases in BMD at
spine and TH.
#1059: Tsai et al Effect of Denosumab
and High-Dose Teriparatide on
Peripheral Bone Mineral Density and
Microarchitecture.
• Results: Higher dose of teriparatide
gives greater increases in Tibial Total
vBMD and radial Ct.vBMD.
36. LB-1166: Fracture Prevention in Osteopenic Postmenopausal Women
with Zoledronic Acid Every 18 Months, a Randomized Controlled Trial
• 6-year, double-blind trial
• 2000 women with osteopenia (T score of −1.0 to −2.5)
• 71 years
• Vitamin D 100.000, followed by 50.000/ month; no calcium supplements
• Median Hip FRAX: 2.3%. four infusions zoledronate 5 mg or normal saline
(placebo group) at 18-month intervals
This article was published on October 1, 2018, at NEJM.org
42. #1007: Black, Geiger, Li, Ryan, Dell, Adams. Bisphosphonate Use and Risk
of AFF Varies by Pre-treatment BMD level.
Background: AFF is associated with duration of
BP therapy.
Question: Does PreRx BMD alter this
relationship?
Design: 152,934 women with preRx BMD and BP
use. 185 cases of AFF adjudicated by two experts
using ASBMR criteria.
Results: Higher PreRx BMD associated with
higher AFF Risk. Time-dependence not influenced
by PreRx BMD
Bars: T-scores
Open: >-1.0
Middle: >-.2.5, < -1.0
Filled: < -2.5
43. #1005: Adams, Li, Ryan, Geiger, Dell, Black.
Do Drug Holidays Reduce Atypical Femur Fracture Risk?
Background: AFF is associated with duration of BP therapy.
Question: Is risk of AFF reduced after stopping BP Rx?
Design: 152,934 women with preRx BMD and BP use. 185 cases of AFF adjudicated
by two experts using ASBMR criteria.
Results: Stopping BP Rx is associated with a marked and progressive reduction in
AFF risk.
Years after DC % Reduction RR (CIs)
1 year 44% 0.56 (0.38-0.82)
1-4 years 80% 0.20 (0.10-0.37)
> 4 years 78% 0.22 (0.08-0.59)
44. #1006: Curtis, Chen, Li, Arora, Saag, Wright, Daigle, Kligore, Delzell.
The Impact of Bisphosphonate Drug Holidays on Fracture Rates.
Background: The incidence of osteoporotic Fxs after the drug holiday is not known.
Question: After three to five years of BP
Rx, is stoppage associated with an
increased in Fx risk?
Design: Medicare database (160,369);
36% drug holiday > 12 months (w/o any
follow up Rx). Mean follow up: 2.7 years.
Compared to continuous BP use.
Results: Drug Holiday > two years is
associated with increased risk of hip
(and humerus) Fx as compared to those who continue BP therapy
47. #1062: Burt, Rose, Emma O. Billington*, Raymond, Hanley, Boyd.
The Calgary Vitamin D Study: Bone Microstructure Effects of 3-yr
Supplementation with 400, 4,000, or 10,000 IU Daily.
Background: Daily doses > 4,000 IU of vitamin D are not recommended (IOM)
Question: Are doses > 4,000 IU/day beneficial by DXA or HRpQCT and FEA
measurements?
Design: 311 healthy men and women with T-scores >-2.5. Baseline 25-OH D 12-50
ng/mL (20-125 nmol/l). Followed for three years.
Results: 25-OH increased to 75 (400 IU); 115 (4,000) and 188 (10,000) nmol/L; No
benefits re DXA or HRpQCT (small reductions) or failure load.
* Most outstanding abstract in Nutrition Research: in Memory of Robert Heaney
48. #1062: Burt, Rose, Emma O. Billington, Raymond, Hanley, Boyd. The Calgary
Vitamin D Study: Bone Microstructure Effects of 3-yr Supplementation with
400, 4,000, or 10,000 IU Daily.
Comment: Is this a reiteration of the Heaney principle on threshold nutrients?
Intake
Effect
No further
benefit
49. #1116: Daniel Dudenkov, Mara, Petterson, Maxson, Thacher.
Serum 25-Hydroxyvitamin D and Risk of Incident Cardiovascular Disease.
Background: Too little and too much vitamin D are both said to be bad for you (the
“inverted J-shaped curve”).
Question: Are values < or > recommended range for 25-OH (50-125 nmol/L)
associated with cardiovascular endpoints?
Design: 11,022 individuals (54 year olds) who had 25-OH levels measured over a
seven-year period. Mean follow 4.8 yrs. Usual CV events defined and recorded.
Results: Average 25-OH D, 75 nmol/L: Relative to range 50-125 nmol/L
• RR risk:
– < 30 nmol/L 1.33 (CI 1.17-1.51)
– 30-50 nmol/L: 1.22 (CI 1.12-1.33)
– >125 nmol/L: 1.15-1.31 (CI 1.00-1.31)
50. #1116: Daniel Dudenkov, Mara, Petterson, Maxson, Thacher. Serum 25-
Hydroxyvitamin D Values and Risk of Incident Cardiovascular Disease.
Worse Not Worse
AnyCVEvent
Continues the discussion about whether 25-OH
levels > 50 ng/mL (125 nmol/l) include risks
52. #1040: Harvey, Oden, Orwoll, Kwok, Karlsson, Rosengren, Ribom, Cawthon,
Ensrud, Cooper, Kanis, Ohlsson, Mellstrom, Johansson, McCloskey. Definitions of
Sarcopenia as Predictors of Fracture Risk Independent of FRAX, falls, and BMD. A
Meta-analysis of MrOS
Background: Predictive value of sarcopenia for incident fractures
Question: Will sarcopenia lose its predictive value if fnBMD, FRAX, prior falls are
taken into effect, across most definitions of sarcopenia?
Design: MrOS (Sweden, USA, Hong Kong). Seven definitions of sarcopenia utilized.
Results: All definitions of sarcopenia (except Studenski) were associated with incident
MOF.
Adjustments: FRAX and prior falls: slight attenuations:
FN BMD alone, however, led to marked attenuation of the relationship to borderline
significance.
53. Conclusion:
Sarcopenia, as generally defined, does not predict Fx when fnBMD is taken into
account.
Other muscle measures, besides those traditionally associated with the definition of
sarcopenia, might help to better establish the relationship between sarcopenia and
skeletal mass.
#1040: Harvey, Oden, Orwoll, Kwok, Karlsson, Rosengren, Ribom, Cawthon,
Ensrud, Cooper, Kanis, Ohlsson, Mellstrom, Johansson, McCloskey. Definitions of
Sarcopenia as Predictors of Fracture Risk Independent of FRAX, falls, and BMD. A
Meta-analysis of MrOS
54. #1041: Cawthon, Peters, Cummings, Orwoll, Hoffman, Ensrud, Cauley,
Evans. Muscle Mass Assessed by D3Cr (deuterated creatine) Dilution and
Incident Fractures in Older Men
The D3Cr dilution method:
• participant ingesting a 30-mg dose of stable isotope-labeled creatine (D3-
creatine)
• fasting, morning urine sample 72–144 hours (3–6 days) later in which D3-
creatinine, unlabeled creatinine, and creatine
• these measures are then included in an algorithm to determine total body
creatine pool size and thus skeletal muscle mass
56. #1041: Cawthon, Peters, Cummings, Orwoll, Hoffman, Ensrud, Cauley,
Evans. Muscle Mass Assessed by D3Cr (deuterated creatine) Dilution and
Incident Fractures in Older Men
Background: Measurements of muscle mass, including ALM/ht2 and whole
body measurements, are dependent on DXA and, thus, do not directly
measure muscle mass. Deuterated creatine (D3Cr), a measure of muscle
mass, is associated with injurious falls and worse physical performance.
Hypothesis: Reduced muscle mass by D3Cr is a risk factor for fracture while
ALM/ht2 is not.
Design: 1388 men (age 84) in year 14 of MrOS. 2.4 years of follow-up.
Adjustments for age, fnBMD, FRAX (with BMD).
57. #1041: Cawthon, Peters, Cummings, Orwoll, Hoffman, Ensrud, Cauley, Evans.
Muscle Mass Assessed by D3Cr (deuterated creatine) Dilution and Incident
Fractures in Older Men
Results: Each SD decrement in D3Cr muscle mass/wgt associated with a 23-25% increased risk of CF or
Non-Vert Fx and 72% increase in risk of hip Fx. ALM/ht2 was not
Conclusion: D3Cr may be a novel risk factor for fracture in older men.
DXA
D3Cr
58. #1060: Daly, Duckham, Tait, Rantalainen, Nowson, Taaffe, Cowan, Hill,
Buxija, Sanders. Effect of Dual-Task Functional Power and Mobility Training
on Falls and Physical Function in Older People Living in Retirement Villages.
Background: Falls are more likely to occur in older people when they are performing
attention-demanding cognitive or motor tasks (i.e. when they are distracted!)
Question: Can dual task training (power training and simultaneous cognitive or motor
task) reduce falls?
Design: 77 year olds (n=300) in retirement villages randomized to training or usual
care; six months of training and six months follow up.
Results: Good news: mobility and muscle power increased and multiple (but not
single) falls were reduced
Bad news: ATTRITION: 50 TO 60%
60. #1109: Samuelson, Dermissie, Adachi, 26 more authors and Kiel. Deficits in
Cortical and Trabecular Bone Microarchitecture Increase Short-term Risk of
Fracture Independently of DXA BMD and FRAX.
Background: There is a need to identify individuals at imminent risk of fracture.
Question: Can HRpQCT indices predict fracture risk over two years?
Design: Seven Cohorts, prospective; 6,763 subjects. Mean age 68; 71% women;
8% FN T-score < -2.5; 55% -1.0 to -2.5; 37% > -1.0.
Results: All cortical indices (except porosity) and all trabecular indices at radius and
tibia showed HRs > 1.0 with or without adjustment for DXA Fn or FRAX for MOF.
Failure load also significantly predictive.
61. #1111: Chapurlat, Sornay-Rendu, Zebaze, Bui, Lespessailles, Seeman.
Deterioration of Bone Microstructure Identifies Women at Imminent Risk of
Fragility Fracture.
Background: There is a need to identify individuals at imminent risk of
fracture.
Question: Can HRpQCT indices predict fracture risk over 2 years?
Design: Two Cohorts, prospective; 1,996 women (age 67). BMD, FRAX, and
Structural Fragility Score (SFS)- cortical porosity/trabecular density index
relative to premenopausal controls
Results: 98 had a fracture after mean of 1.06 years.
62. #1111: Chapurlat, Sornay-Rendu, Zebaze, Bui, Lespessailles, Seeman.
Deterioration of Bone Microstructure Identifies Women at Imminent Risk of
Fragility Fracture.
Results: Neither BMD nor FRAX was predictive.
SFS > 70: 14/20 identified when BMD < -2.5 (OR: 3.95)
29/78 identified when BMD ‘osteopenic’ (OR: 3.01)
19/24 women > 70 with MOF (OR: 8.52)
Conclusion: Most women at imminent risk for fracture (i.e. within two
years) cannot be identified by BMD or FRAX but can be identified by
identifying microstructural deterioration.
64. #1038: Morin, Yan, Lix, Leslie. Changes in the Risk of Subsequent Major
Osteoporotic Fractures over Time in Men and Women: A Population-Based
Observational Study with 25-year follow up.
Background: A fracture begets a fracture and begets another fracture
Question: Over an extended 25-year period of observation, does fracture
risk remain elevated after the fracture?
Methods: Administrative Canadian healthcare database; 17,721 men;
57,783 women > 50 who sustained an index MOF ‘89-’06.
65. #1038: Morin, Yan, Lix, Leslie. Changes in the Risk of Subsequent Major
Osteoporotic Fractures over Time in Men and Women: A Population-Based
Observational Study with 25-year follow up.
Results: Risk over 15
years was sustained over
historical controls with risk
in men>women for all ages
except > 80. Risk was
higher and attenuated
more so in men.