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Osteoporosis clinical trials

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NCT ID: NCT03819478 Enrolling by invitation - Obesity Clinical Trials

Utilizing Protein During Weight Loss to Impact Physical Function and Bone

UPLIFT-Bone
Start date: May 3, 2017
Phase:
Study type: Observational

This study is an ancillary study to the UPLIFT trial (NCT03074643) to evaluate the effects of diet composition (i.e., amount of protein and carbohydrate) during a 6-month weight loss intervention and 12-months of follow-up on bone phenotypes in obese older adults. Participants will receive either a protein or carbohydrate supplement along with a behavioral weight loss intervention.

NCT ID: NCT03512743 Enrolling by invitation - Clinical trials for Postmenopausal Osteoporosis

Association of Serum Ferritin and Bone Mineral Density With Bone Metabolism in Chinese Healthy Postmenopausal Women

Start date: May 1, 2018
Phase:
Study type: Observational

Large amounts of experimental and animal evidence have confirmed that iron accumulation is associated with bone loss. However, it is still lack of the clinical studies relating iron accumulation to bone loss, especially in the pathological conditions during our Chinese. In this study, the investigators aim to assess the association between the levels of serum ferritin and bone mineral density in Chinese healthy postmenopausal women.

NCT ID: NCT03475719 Enrolling by invitation - Clinical trials for Osteoporosis, Postmenopausal

A Clinical Trial to Evaluate the Safety and Pharmacokinetic

Start date: January 11, 2018
Phase: Phase 1
Study type: Interventional

A phase 1 clinical trail to evaluate the safety and pharmacokinetic characteristic after administration of fixed-dose combination or loose combination of HUG186 in healthy adult male or menopausal female volunteers

NCT ID: NCT03463850 Enrolling by invitation - Osteoporosis Clinical Trials

Analysis of Bone Micro-Architecture as a Clinical Biomarker for Image-Based Fracture Risk Estimation.

Start date: June 2016
Phase: N/A
Study type: Interventional

Osteoporosis is a common disease among elderly people, which leads to an increased bone fracture risk. Bone fractures can greatly reduce quality of life and increase age-related problems including reduced life expectancy. In clinical practice, a bone mineral density (BMD) scan using dual-energy X-ray absorptiometry (DEXA) is used for diagnosing osteoporosis. However, DEXA does not always accurately predict who will develop fractures and who will not. This is because bone mineral density alone does not capture all of the factors that contribute to bone strength. One factor bone mineral density does not measure is trabecular microarchitecture of bone (structure of bone). Our goal in this study is to use a specialized CT scan called Dual-Energy CT (DECT) to capture information about the trabecular (spongy) bone in the vertebra of the lower (lumbar) spine. Research has shown that this kind of information helps in predicting bone strength in bone specimens. The investigator will use this information to develop a method to more accurately predict which patients are likely to experience fractures of the lumbar vertebra. These are the most common type of fractures associated with osteoporosis. The participant is being asked to participate in this research study because a physician is treating the participant for osteoporosis and the participant has met the initial criteria to participate in the study. Participation in this study involves having a DECT scan, as well as a DEXA scan if the participant has not had one recently (within two months). Research studies include only those individuals who choose to take part. Please take time to make a decision. Please ask the study doctor or the study staff to explain any words or information that are not understood. The participant may also want to discuss it with family members, friends or other health care providers.

NCT ID: NCT03242512 Enrolling by invitation - Osteoporosis Clinical Trials

Assessment of Anti-RANKL Antibody in Post-menopausal Women

Start date: August 7, 2017
Phase: Phase 1
Study type: Interventional

This is a single-center, open-label, dose-escalating study to evaluate the safety, pharmacokinetics, immunogenicity, and preliminary efficacy of single dose subcutaneous injection of a fully human monoclonal antibody of receptor activator for nuclear factor-κ B ligand (RNAKL) (code name: TK006) in postmenopausal women.

NCT ID: NCT03178799 Enrolling by invitation - Clinical trials for Osteoporosis Fracture

Randomized Fracture Liaison Services

Start date: June 23, 2017
Phase:
Study type: Observational

Aims: To compare clinical outcomes for patients under FLS and usual care at the NTUH MH and BB. Method: Four hundred subjects with new hip fracture or newly identified vertebral fracture are randomly assigned into FLS and usual care (UC). FLS subjects received osteoporosis-related assessments, treatments, consultations on diet, medications, exercise, fall preventions given mainly by care managers with followed up telephone call at 4, 8, 12, 18, 24 months then annually for up to 10 years. Care managers will perform baseline assessments and follow them by telephone annually for up to 10 years for UC subjects. Major outcomes include bone mineral density assessment rate, calcium, vitamin D, and osteoporosis medication initiation and adherence rate, fall and fracture incidences, mortality, and healthcare resource utilizations.

NCT ID: NCT02814591 Enrolling by invitation - Osteoarthritis Clinical Trials

Development of a Non-invasive Assessment of Human Bone Quality Using Spatially Offset Raman Spectroscopy

Start date: October 2011
Phase: N/A
Study type: Observational [Patient Registry]

In this study spatially offset Raman spectroscopy (SORS), which allows the collection of Raman spectra through turbid media, is being applied to collect Raman spectra of bone. The principal aim to find ways to use Raman spectroscopy to assess bone quality in vivo.

NCT ID: NCT02436356 Enrolling by invitation - Osteoporosis Clinical Trials

New Tools for Assessing Fracture Risk

Start date: June 30, 2015
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02014038 Enrolling by invitation - Osteoporosis Clinical Trials

Ultrarunners Longitudinal TRAcking Study (ULTRA)

Start date: May 2011
Phase: N/A
Study type: Observational [Patient Registry]

Health status information and physical activity level will be collected longitudinally on a large group of individuals who are ultramarathon runners at the time of enrollment to determine if very high levels of physical activity alter health risks compared with sedentary or moderately active lifestyles.

NCT ID: NCT01963039 Enrolling by invitation - Osteoporosis Clinical Trials

A Trial of Vertebroplasty for Painful Chronic Osteoporotic Vertebral Fractures (Vertos V)

VERTOSV
Start date: May 2013
Phase: N/A
Study type: Interventional

Background The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is a relatively new treatment option. Recent randomized controlled trials (RCT) provide conflicting results: two sham-controlled studies showed no benefit of PV while an unmasked but controlled RCT (VERTOS II) found effective pain relief at acceptable costs in patients with acute VCFs. A still ongoing masked RCT (VERTOS IV) focuses on acute VCFs defined as ≤ 6 weeks. VERTOS III focused on conservative treatment and found that half of patients still had disabling pain after 3 months or longer. These patients with sustained pain after 3 months may benefit from PV. Objective To compare pain relief after PV with a sham intervention in selected patients with a chronic osteoporotic VCF ( three months or longer) using the same strict inclusion criteria as in VERTOS II an IV. Secondary outcome measures are back pain related disability and quality of life. Methods The VERTOS V study is a prospective RCT with pain relief as primary endpoint. Inclusion criteria are a VCF of thoracic level 5 or lower with focal tenderness at fracture level, assessed by an internist on physical examination and a Visual Analogue Scale (VAS) score ≥ 5 for three months or longer, decreased bone density defined as T score ≤ -1 and age 50 years or older. 94 patients will be included, 47 in each arm. Crossovers are not allowed. Follow-up is at regular intervals during one year period with VAS score for pain as primary endpoint. Secondary endpoints are back pain related disability and quality of life measured with the Quality of Life Questionnaire of the European Foundation for Osteoporosis and physical function measured with the Roland Morris Disability questionnaire. Conclusion Vertos V is a methodologically sound masked randomised sham controlled trial of vertebroplasty in patients with sustained pain 3 months or longer after a vertebral compression fracture.