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Osteoporosis, Age-Related clinical trials

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NCT ID: NCT05927623 Recruiting - Aging Clinical Trials

Multifaceted Intervention Using Telehealth to Reduce the Risk of Falls and Fractures in Older Men

MisterFIt
Start date: February 7, 2023
Phase: N/A
Study type: Interventional

Men sustain over one-third of osteoporosis-related fractures worldwide. The burden of osteoporotic fractures in older men is substantial, and men suffer significantly worse fracture-related outcomes than women. Following a fracture, men sustain greater rates of subsequent fractures, loss of autonomy, and mortality than women and the imminent risk of re-fracture is several times higher in men than in women. Functional mobility, known to predict falls and fractures, is also notably worse in men following a fracture. In the fiscal year 2007-08, the overall annual costs of osteoporosis in Canadian men was evaluated to be $910 million. Osteoporosis is primarily considered a disease of older women, and men are remarkably under-evaluated and under-treated for it. Recognition of sex and gender influences on skeletal health in men has been very slow; akin to the gap in cardiovascular diseases, where women are far less likely to receive guideline-recommended investigations and treatment. Over 85% of Canadian men who suffer from fragility fractures do not receive osteoporosis screening and/or treatment strategies. The existence of this care gap in men underscores our current struggle to overcome important barriers including: 1) men's lack of awareness of the critical impact of osteoporosis and fractures on several aspects of their lives, and of the benefits of treatment; and 2) the absence of comprehensive and accessible treatments tailored to men. Informed by the Knowledge-to-Action framework, we aim to address these barriers by adapting interventions with proven efficacy to engage men at high fracture risk in health behaviour change. The current protocol is for a pilot RCT to determine the feasibility of recruitment and retention, adherence to, and acceptability of the virtually-delivered fracture prevention intervention only. Our long-term goal is to conduct a large pragmatic randomized controlled trial (RCT) to address the research question: In older adults at high risk for fractures who self-identify as men, does anti-osteoporosis pharmacotherapy in conjunction with a virtually-delivered intervention that includes a gender-tailored strength training and balance based exercise program and nutritional counselling, improve functional mobility compared to anti-osteoporosis pharmacotherapy in conjunction with an attention control intervention.

NCT ID: NCT05197244 Completed - Osteoporosis Risk Clinical Trials

A Culinary Intervention for Bone Health

Start date: July 15, 2022
Phase: N/A
Study type: Interventional

This is a randomized, controlled pilot study to evaluate the feasibility and acceptability of a single 2-hour culinary medicine intervention for bone health among individuals with age-associated low bone mass.

NCT ID: NCT04167150 Completed - Clinical trials for Osteoporosis, Postmenopausal

Tart Cherry Supplementation and Women's Bone Health Study

Start date: June 6, 2017
Phase: N/A
Study type: Interventional

In spite of aggressive approaches to prevent and treat osteoporosis, it remains one of the most costly and debilitating diseases associated with aging. The pursuit of alternative approaches for preventing bone loss has included the investigation of a number of promising plant-based foods that can be incorporated into the diet. This project is an extension of our pre-clinical studies with tart cherry, designed to determine whether the findings from our animal study can be extended to humans. Thus, the purpose of this project is to investigate the dose-dependent effect of tart cherry juice consumption on biomarkers of bone metabolism in women, aged 65-80 years. The hypothesis to be tested is that three months of tart cherry supplementation will improve bone biomarkers in a dose-dependent manner. Moreover, these improvements in bone metabolism will correspond to a decrease in markers of inflammation and oxidative stress.

NCT ID: NCT03710889 Completed - Osteoporosis Clinical Trials

Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption

Start date: September 20, 2018
Phase: Phase 3
Study type: Interventional

The objective of this study is to measure the early effects of abaloparatide on tissue-based bone formation using samples obtained by transiliac crest bone biopsy after quadruple fluorochrome labeling.

NCT ID: NCT03512262 Completed - Osteoporosis Clinical Trials

Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)

Start date: May 3, 2018
Phase: Phase 3
Study type: Interventional

A 12-month study to measure the efficacy and safety of abaloparatide in men with osteoporosis.

NCT ID: NCT02732210 Completed - Clinical trials for Osteoporosis, Age-Related

Persistence With Prolia® (Denosumab) in Postmenopausal Women With Osteoporosis

Start date: July 6, 2011
Phase:
Study type: Observational

The objective of this study was to describe persistence with Prolia® 60 mg administered subcutaneously (SC) every 6 months (Q6M) at 12 and 24 months.

NCT ID: NCT02467400 Completed - Clinical trials for Osteoporosis, Age-Related

Dose Response and Receptor Selectivity of Beta-blocker Effects on Bone Metabolism

Start date: July 1, 2015
Phase: Early Phase 1
Study type: Interventional

This study is designed to answer the question as to whether the sympathetic nervous system is an important determinant of bone metabolism in humans.

NCT ID: NCT02091492 Withdrawn - Humeral Fractures Clinical Trials

Teriparatide for Fracture Repair in Humans

TERAFRAP
Start date: June 2014
Phase: Phase 3
Study type: Interventional

This study will test the hypothesis that daily subcuaneous administration of 20µg of teriparatide (TPTD) as compared to daily subcuaneous placebo for twelve weeks accelerates proximal 2-segment humerus fracture healing and improves the three dimensional structural properties of bone as measured via quantitative bone image analysis and finite element modeling assessed by quantitative computed tomography.

NCT ID: NCT01475214 Completed - Muscle Loss Clinical Trials

Musculoskeletal Effects of Bicarbonate

Start date: January 2012
Phase: Phase 2
Study type: Interventional

With aging, men and women develop a mild and progressive metabolic acidosis. This occurs as a result of declining renal function and ingestion of acid-producing diets. There is extensive evidence that severe metabolic acidosis causes bone and muscle loss, but the impact of the chronic, mild acidosis on bone and muscle in older individuals has not been established. In a recent study, administration of a single dose of bicarbonate daily for 3 months significantly reduced urinary excretion of N-telopeptide (NTX), a marker of bone resorption and urinary nitrogen, a marker of muscle wasting and improved muscle performance in the women but not the men. These and other data support a potential role for bicarbonate as a means of reducing the musculoskeletal declines that lead to extensive morbidity and mortality in the elderly. Before proceeding to a long-term bicarbonate intervention study, however, it is important to identify the dose of bicarbonate most likely to be optimal and to characterize the subjects who benefit most from it. This double blind, placebo controlled, dose-finding study will evaluate the effects of placebo and two doses of bicarbonate on urinary NTX and nitrogen excretion and on lower extremity performance over a 3 month period in 138 men and 138 women, age 60 and older. Changes in urinary excretion of NTX and nitrogen and in selected measures of lower extremity performance will be compared across the three groups. The safety and tolerability of the interventions will also be evaluated. This investigation should provide needed information on the appropriate dosing regimen for men and women and on the study population that should be enrolled in a future bicarbonate intervention trial to assess the long-term effects of this simple, low cost intervention on important clinical outcomes including rates of loss in bone and muscle mass, falls, and fractures.