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Osteoporosis Clinical Trials

Browse current & upcoming clinical research / studies on Osteoporosis. There are a total of 465 clinical trials for Osteoporosis in 27 countries with 24 trials currently in the United States. 62 are either active and/or recruiting patients or have not yet been completed. Click the title of each study to get the complete details on eligibility, location & other facts about the study.

Other clinical trials

Definitions
Interventional trials
Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Observational trials
Address health issues in large groups of people or populations in natural settings.
Recruiting
Participants are currently being recruited and enrolled.
Active, not recruiting
Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
Not yet recruiting
Participants are not yet being recruited or enrolled.
Enrolling by invitation
Participants are being (or will be) selected from a predetermined population.
Completed
The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
Withdrawn
Study halted prematurely, prior to enrollment of first participant.
Suspended
Recruiting or enrolling participants has halted prematurely but potentially will resume.
Terminated
Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
June 2015 - June 2018
The purpose of this study is to evaluate denosumab as a novel treatment for bone loss in children treated with glucocorticoids for rheumatic disorders. This is a pilot Phase 1/2, randomized open-label, 12-month clinical trial of denosumab to assess its effect on bone resorption markers and bone mineral density (BMD) in children with rheumatic disorders, age 4 to 16 years, recruited within 1 month of starting a chronic systemic glucocorticoid regimen. Primary outcomes include suppression of bone turnover markers and safety assessments. Secondary outcomes include changes in bone density as measured by dual energy X-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) densitometry at the radius and tibia.
Sponsor: Indiana University
Study type: Interventional
April 2015 - June 2016
The purpose of this study is to validate the long-term benefit of denosumab for osteoporosis treatment in a real-world clinical practice setting. We hypothesize that continued therapy (36+months) with denosumab will increase both trabecular bone score (TBS) and femur strength index (FSI) and reduce fracture and other bone health risks among post-menopausal women with osteoporosis.
Sponsor: HealthEast Care System
Study type: Observational
April 2015 -
Diabetes mellitus is a common disease with much impact on human's health and is related to osteoporosis. But the mechanism remains unclear. Some researches revealed thiazolidinedione (TZD) would increase the risk of osteoporosis and bone fracture, especially elderly women. However, it is still controversial in terms of the youth and men. In Taiwan, there is few related study to analyze the relationship between TZD and osteoporosis. This is a multiple center, open-labeled, controlled, randomized, parallel study. 400 of subjects over 40 years old, including men and postmenopausal women, are planned. Subjects must be consenting adult volunteers who were diagnosed with type 2 diabetes mellitus, whose recent HbA1c level are between 7.0~8.5% and only receive oral anti-diabetic drugs for at least 3 months. Subjects ever received TZDs or DPP4-inhibitors prior to this study will not be enrolled. Each subject will be administered with added-on either pioglitazone or linagliptin one dose per day for total 48 weeks. Subjects will be assigned to the treatments in random order. The primary objective is to assess the effect of TZD on skeleton as measured by the change in bone mineral density and bone turnover markers over the 12 months treatment period. The secondary objective is to assess the effect of TZD on kidney by measurement of eGFR, doubling time of serum Cr level, UACR and urine biomarkers over the 12 months treatment period. The tertiary objective is to assess the possible effect of TZD on the changes in the eye ground of the patients and calculate the incidence of TZD-related macular edema over the 12 months treatment period.
Sponsor: National Taiwan University Hospital
Study type: Interventional
April 2015 - April 2016
The goal of this study is to determine whether two new, non-X-ray techniques can discriminate between high-energy fractures of normal bone (trauma) and low-energy fractures (fragility) of osteoporotic bone. The current gold-standard for assessing fracture risk areal bone mineral density (aBMD) by dual energy X-ray absorptiometry (DXA) is not particularly effective at identifying individuals who are at risk of suffering a fracture. Yet, there is a growing population of diabetics and elderly individuals prone to fractures. In effect, the age-related and diabetes-related increase in fracture risk is independent of a person's aBMD. These findings stress the urgency in developing diagnostic tools that can improve fracture risk prediction so that patients can be treated with the appropriate anti-fracture therapies.
Sponsor: Vanderbilt University
Study type: Interventional
March 2015 - November 2018
There are over 10 million individuals with asthma using inhaled glucocorticoids (IGCs) in the United States. While oral GCs are recognized to have destructive skeletal effects, far less is known about the effects of IGCs. This gap in our knowledge is of critical importance, not only because of the prevalence, chronic nature and long duration of IGC use, but also because several studies have found that patients using IGCs are at increased risk of fracture. Fracture risk is greatest in postmenopausal (PM) women, in whom IGCs may augment negative effects of estrogen loss and aging. The investigators hypothesize that initiation of IGCs in IGC naïve PM women will lead to decreased bone formation and uncoupling of bone turnover, a potential mechanism for the effect of IGCs on the skeleton. To test our hypothesis, the investigators will perform a randomized, controlled 4 week study of the acute effects of commonly used doses of budesonide (360 or 720 mcg) on bone turnover and circulating osteoblast precursors in 60 treatment naïve, non-asthmatic, PM women. These studies are of high clinical significance because there are currently no guidelines regarding screening, prevention or treatment for osteoporosis in patients using IGCs, nor is IGC use taken into account when calculating fracture risk in PM women, the group at highest risk of fracture. High quality evidence for low volumetric bone mineral density (BMD) and abnormal bone quality in PM women using IGCs has the potential to change clinical practice by supporting specific interventions to prevent bone loss and fractures.
Sponsor: Columbia University
Study type: Interventional
February 2015 - February 2016
This pilot study evaluates the effect of theory menu-based mini-videos on vitamin D adherence in older adult with osteoporosis. Half of participants will watch the videos while the other half will receive usual care (treating physician advice).
Sponsor: McMaster University
Study type: Interventional
February 2015 - December 2018
The purpose of this study is to elucidate the role of Dental Cone Beam Computed Tomography (CBCT) in assessment of bone density. The study population contains men and women above the age of 60 years, eligible for Bone Density Testing in accordance with their health insurance, who underwent a Dental CBCT recommended by their Dental Practitioner. Any patient (eligible for bone density screening by age criteria) undergoing CBCT of either one of the jaws (or both) due to dental reasons, will be sent to a bone mineral density DEXA Scan, and for blood testing for PTH, Phosphor, Calcium ,Vitamin D and Creatinine levels. Density measurements will be done in specific sites on the CBCT's of the jaws. These measurements will be correlated with the blood tests and DEXA scan results.
Sponsor: Soroka University Medical Center
Study type: Observational
January 2015 - June 2016
Osteoporosis is a large public health disease, characterized by low bone mass and micro architectural deterioration of bone tissue, resulting in enhanced bone fragility and consequent increase in fracture risk. Osteoporosis is present when bone mineral density (BMD) or content (BMC), measured by dual-energy X-ray absorptiometry (DXA), is more than 2.5 SDs below the mean value of the young adult. BMD measured by DXA is a surrogate measure of bone strength and is the primary determinant of fracture risk in both men and women. However, the majority of fragility fractures occur in women and in individuals who do not have osteoporosis according to these standards, indicating that BMD is just one among several indicators of bone health and that assessment of fracture risk should also rely on other bone properties. Newer imaging methods, such as quantitative computerized tomography (QCT), can complement information from DXA-measurements due to its ability to assess volumetric BMD and bone geometry and to differentiate between cortical and trabecular bone compartments. Bones are composite materials made predominantly of living cells, extracellular matrix, water and lipids. This composite nature of the bone material enables it to absorb stresses by elastic deformation and to endure high loads before fracturing. A new in vivo measurements of bone material strength can be used to evaluate bone mechanical properties and thereby the fracture risk. It is well established that the skeleton benefits, in terms of increased density, from regular physical activity. However, changes in BMD are still the main surrogate for assessing improvements in exercise-induced bone health despite the experimental findings as well as findings in humans showing that improvements in mechanical bone properties are independent of changes in BMD. These improvements in mechanical bone properties may be due to changes in bone shape or matrix composition. It could then be argued that a decrease in BMD is only one of the possible manifestations of osteoporosis and that bone strength or fragility is multifactorial. The objective for this study is to investigate the role of mechanical loading on bone material strength and bone microarchitecture in middle-aged women. The overall hypothesis is that mechanical loading is a regulator of bone material strength and microarchitecture in middle-aged women. This is an intervention study where the participants will act as their own controls. The investigators intend to include 40 postmenopausal and healthy women 50-60 years of age in the study. Advertisements in local papers and at the hospital will be used to come into contact with suitable study subjects. The women will be asked to perform an intervention program, including jumping on one leg every day during a 3-month period according to a protocol with a gradually increasing load/number of jumps. The women have to choose one of their legs as intervention-leg and stick to the chosen leg throughout the study. The leg without intervention will be used as a control. Both bone material strength (BMS) and bone microarchitecture will be measured before and after intervention in both legs (tibia). The operators measuring BMS (OsteoProbe®) and bone microarchitecture (high resolution pQCT) will be blinded concerning each participant's choice of leg for intervention. In addition, subjects will be asked to register daily physical activity in a structured diary. The primary outcome measure will be changes in bone material strength (BMS) in the lower leg (tibia) with intervention compared to the leg (tibia) without intervention. Participants will attend two clinic visits, at baseline and after 3 months when the intervention period is completed. The secondary outcome measures will be changes in total volumetric density, cortical volumetric density, cortical cross sectional area and trabecular bone volume fraction in the lower leg (tibia) with intervention compared to the leg (tibia) without intervention.
Sponsor: Sahlgrenska University Hospital, Sweden
Study type: Interventional
January 2015 - May 2018
Sublesional bone loss after acute spinal cord injury (SCI) is sudden, progressive, and dramatic. After depletion of bone mass and the loss of architectural integrity, it may be difficult, if even possible, to restore skeletal mass and strength. Denosumab is a relative new, highly potent anti-resorptive agent that has proven efficacy in postmenopausal osteoporosis to improve bone mass and in solid tumor patients to prevent a skeletal-related event to a greater extent than that with bisphosphonate administration. In persons with complete motor lesions, bisphosphonates have not been effective at reducing bone loss at the knee, the site of greatest relevance because of its increased risk of fracture. Anti-RANKL therapy appears to be more potent than bisphosphonates in animal models of bone loss due to immobilization, suggesting that treatment with denosumab may prove to be an efficacious therapy for persons with acute SCI to preserve bone mass and strength.
Sponsor: James J. Peters Veterans Affairs Medical Center
Study type: Interventional
January 2015 - July 2017
This is a dose escalation study to determine the maximum tolerable dose of Parathyroid Hormone-related Protein, PTHrP, or Parathyroid Hormone, PTH, that can be given safely over one week in healthy African-American volunteers. The investigators plan to infuse low doses of intravenous PTHrP or PTH to determine if it leads to a sustained and progressive suppression of bone formation as occurs in humoral hypercalcemia of malignancy (HHM) or an increase in bone formation as occurs in hyperparathyroidism (HPT). Additionally, the investigators will assess the direct influence of PTHrP and PTH on vitamin D metabolism, markers of bone turnover, and fractional excretion of calcium. These results will be compared to previous studies of Caucasian volunteers.
Sponsor: University of Pittsburgh
Study type: Interventional
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