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Osteoporosis clinical trials

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NCT ID: NCT04029870 Completed - Clinical trials for Osteoporosis, Postmenopausal

Psychological Determinants of the Therapeutic Observance of Osteoporotic Patients

OSTEOPSY
Start date: June 17, 2019
Phase:
Study type: Observational

Osteoporosis is a skeletal pathology characterized by decreased bone mass and deterioration of bone tissue. This pathology affects predominantly women, which is estimated that 40% of them will suffer an osteoporotic fracture. The incidence of osteoporosis, thus representing a major public health problem where osteoporotic fractures have a higher incidence than those combined with cardiovascular disease and breast cancer (INSERM, 2016; WHO 2008). It causes traumatic fractures that have the effect of dependence and loss of functional autonomy associated, in terms, with the risk of a reduction in life expectancy. The management of osteoporosis therefore becomes an issue for rheumatologists. The latter involves both compliance with hygienic-Dietetic measures (such as calcium intake, physical activities, prevention of falls...) and medicated treatments whose action is intended, for some, to block bone destruction or, for others to stimulate bone formation. The efficacy of drug treatments is now proven, these treatments are however profitable only if the therapeutic adherence of the patients is maximal. However, rheumatologists and researchers generally find an average rate of 70% enrolment after 6 months of treatment, most often lowered to 50% after 12 months of treatment, thus increasing fractures. On the other hand, the literature informs the medical and educational aspects of the problem of non-observance in osteoporotic patients, but curiously, it does not say anything of the psychological aspects likely to be linked to these behaviors of non-adherence to therapy. The objective of this thesis work is to take an interest in the underlying psychological determinants that may explain the behaviour of adherence and/or non-adherence of osteoporotic patients.

NCT ID: NCT04026256 Completed - Clinical trials for Postmenopausal Osteoporosis

Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration

Start date: September 2, 2019
Phase: Phase 4
Study type: Interventional

The purpose of this study is to examine, via iliac crest bone biopsies, the mechanism of combined teriparatide and denosumab on the bone of postmenopausal osteoporotic women after 3 months of treatment.

NCT ID: NCT04019938 Recruiting - Diabetes Mellitus Clinical Trials

Association of Cystatin C and Bone Mineral Density in Diabetic Patients.

Start date: July 4, 2019
Phase:
Study type: Observational

Type 1 diabetes is associated with low bone mineral density(BMD) and type 2 diabetes with normal or high BMD. Cystatin C is a small molecule that is used to measure kidney function but it's not a troponin of the kidney. It has been associated with many other diseases like atrial fibrillation, depressive symptoms, melanoma, etc. This crossectional clinical study was done to evaluate the association between Cystatin C and Bone mineral density in both types of diabetic patients.

NCT ID: NCT04008459 Terminated - Osteoporosis Clinical Trials

Walking and Balance Related to Sagittal Spinal Posture Alignment

WiSPA
Start date: April 6, 2019
Phase:
Study type: Observational

This study aims to improve understanding of the relationship between spinal alignment and walking and balance in people who have degenerative spinal conditions.

NCT ID: NCT04003467 Completed - Osteoporosis Clinical Trials

A Six-month Phase 2 Study of Oral hPTH(1-34) (EBP05) in Postmenopausal Women With Low Bone Mass

Start date: June 30, 2019
Phase: Phase 2
Study type: Interventional

This is a double-blinded randomized study to determine the effects of treatment on biochemical markers of bone formation and bone resorption, and bone mineral density (BMD) for 6 months of treatment with EBP05 or placebo. Approximately 160 postmenopausal women with low bone mass (BMD T-score lower than or equal to -2.0 in at least one location: Lumbar Spine, Femoral Neck or Total Hip sites) over 50 years of age will receive Study Medication. Protocol Version 3.0 describes the treatment and evaluation of the initial 103 subjects randomized. In Protocol Version 4.0 the treatment phase will consist of 4 different treatment arms as follows: Oral EBP05 0.5mg x3 tablets (1.5mg), N=6 Oral EBP05 0.5mg x5 tablets (2.5mg), N=36 Oral Placebo for EBP05 0.5mg (split to sub-groups of: 3 or 5 tablets), N=18

NCT ID: NCT03999528 Completed - Clinical trials for Rheumatoid Arthritis

14-3-3η Protein, Disease Activity and Bone Mineral Density, in Female Patients With Rheumatoid Arthritis

Start date: May 1, 2019
Phase:
Study type: Observational

Is to investigate the relation between 14-3-3η protein, disease activity, and bone mineral density in female patients with rheumatoid arthritis.

NCT ID: NCT03997682 Not yet recruiting - Osteoporosis Clinical Trials

Hands-Up: Exercise and Education Program After a Wrist Fracture

Start date: March 10, 2021
Phase: N/A
Study type: Interventional

Osteoporosis is a bone disease that increases the risk of fractures. People aged 50-65 diagnosed with osteoporosis feel too young to have the disease. But this happens. They need to learn how to modify their lifestyle to minimize the chances of fractures. In this age group, a wrist fracture is usually the first sign of osteoporosis. Fracture risk increases if they are not taught to exercise, eat properly, and identifies fall risk factors early in their diagnosis. Some studies have looked at interventions for osteoporosis in women over the age of 65, but by this age they have likely already had a spine fracture. No studies have addressed the early-onset osteoporosis age group, intervening before spine fractures occur. I will develop an exercise, nutrition, and falls prevention education program to improve the strength, balance and knowledge of people aged 50-65 who had an osteoporotic wrist fracture. I will use this treatment approach and determine if it is more effective than the usual way of treating people with wrist fractures, determining if this is a better strategy for managing osteoporosis. I will have two groups of patients. First, those, over six weeks, receive twice weekly classes that include exercise and education. Here the focus is on bone health and fracture prevention. The control will receive usual physical therapy and the educational materials at the end of their study participation. The treatment will be randomly allocated to 74 men and women between the ages of 50-65 years of age who are 6-10 weeks post-fracture. The outcomes on both groups will be assessed and compared. I will focus on hand function, balance, fall hazard detection, and a bone health behaviour checklist. Using these outcomes, I can determine which treatment approach works best. Osteoporosis affects one in three women and one in five men, making this an important study to improve the lives for many Canadians. The risk of osteoporosis fractures increases with age, making early interventions critical.

NCT ID: NCT03994172 Recruiting - Male Osteoporosis Clinical Trials

Novel Combination Therapy for Osteoporosis in Men

Osteo-Men
Start date: July 1, 2019
Phase: Phase 4
Study type: Interventional

Osteoporotic fractures are a key health problem in older men. Although there are drugs approved to treat osteoporosis in men [bisphosphonates, denosumab, and teriparatide (TPTD) or PTH(1-34)], there is a lack of knowledge on how to use them effectively. TPTD is a potent bone anabolic drug, meaning that it builds bone mass. However, doctors do not know if it should only be used as single drug or whether it can be more effectively combined to achieve the most benefit? This trial will test a novel combination therapy for osteoporosis in men based on exciting laboratory findings in mice. TPTD works to raise bone mass and improve bone strength by stimulating PTH receptors (PTH-Rs) on the membranes of bone-forming cells or osteoblasts (OBs). Calcimimetics are drugs that activate calcium receptors (CaSRs) in OBs. CaSRs in OBs participate in new bone formation. Daily injections of TPTD, given along with a calcimimetic drug (called NPS-R568), over 6 weeks markedly improved bone mineral density (BMD) and structure in mice. This study will test whether the combined activation of PTH-Rs and CaSRs (by the combination treatment of TPTD+calcimimetic cinacalcet) in men will produce greater bone forming responses than PTH-R activation alone (TPTD+placebo). The study has two aims and will be done in 48 men with low bone mass: (1) to determine the effects of 11 months treatment with TPTD+cinacalcet vs TPTD+placebo on BMD and bone metabolism by assessing lumbar spine BMD (primary endpoint), femoral neck BMD, and levels of the bone formation marker serum N-terminal pro-peptide of type 1 collagen; (2) to determine the biochemical responses by blood tests in men who receive the combination of TPTD+cinacalcet compared to men who get TPTD+placebo treatment. This is done by quantifying acute and chronic changes in serum calcium and PTH levels right after these drugs are given and how much calcium is excreted in the urine over time, with both treatment regimens. This study will help to understand whether an effective combination therapy in mice will prove to be effective in men.

NCT ID: NCT03994094 Enrolling by invitation - Osteoporosis Clinical Trials

Three Year Evaluation of a Cohort of Patients Presenting Osteoporotic Fractures

Start date: June 12, 2019
Phase:
Study type: Observational

A specialized osteoporosis clinic has existed in our hospital since 2010. The descriptive retrospective analysis of patients included in this pathway was the subject of a first study on patients included between January 2010 and January 2011 and reported to the Congress of the French Society of Rheumatology (SFR) in December 2011, then a second study on patients included between January 2012 and December 2016, presented as an e-poster at the SFR Congress in December 2017 and in a poster at the American Society of Bone and Mineral Research Conference (ASBMR) in October 2018 and published in 2019 in Archives of Osteoporosis. The effectiveness specialized osteoporosis clinics is the subject of numerous publications. It therefore seems important to evaluate the effectiveness of our management, 3 years from the date of inclusion of patients in the osteoporosis clinic of our hospital.

NCT ID: NCT03974100 Completed - Clinical trials for Postmenopausal Women With Osteoporosis

Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis

Start date: July 2, 2019
Phase: Phase 3
Study type: Interventional

This study was conducted to assess if there were any clinically meaningful differences in pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, or immunogenicity between GP2411 (proposed biosimilar denosumab) and EU-authorized Prolia® (denosumab).