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Postmenopausal Osteoporosis clinical trials

View clinical trials related to Postmenopausal Osteoporosis.

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NCT ID: NCT06457308 Completed - Clinical trials for Postmenopausal Osteoporosis

Compare the Agility Exercise and Resistance Exercise on Physical Function and Stability in Osteoporotic Women

Start date: July 14, 2021
Phase: N/A
Study type: Interventional

Osteoporosis weakens bones with age, increasing fracture risk. Exercise improves physical function and reduces falls, crucial for preventing osteoporotic fractures, especially with balance, resistance, and multi-component training. Agility exercise, integrating various aspects like aerobic, strength, balance, and cognitive tasks, is promising for fall prevention in older adults, though its effectiveness in osteoporosis is not extensively studied. This study compares agility and resistance exercise impacts on physical function and balance stability in postmenopausal osteoporosis. Fifty-one women (average age: 68±6.3y, BMI: 22.3±2.7 kg/m2) were divided into agility exercise (AG), resistance exercise (RG), and control groups (CG) through purposive sampling. AG and RG received added intervention training once a week for 2 hours over 12 weeks. Main outcomes included physical function and balance stability measured through various tests.

NCT ID: NCT05650437 Completed - Clinical trials for Postmenopausal Osteoporosis

Impact of Ultraviolet Radiation on Bone Density and Muscle Strength in Postmenopausal Women

Start date: December 30, 2022
Phase: N/A
Study type: Interventional

70 postmenopausal women, aged 50 to 60, who are vitamin D deficient and diagnosed with osteoporosis or osteopenia with T score of DEXA of lumbar spine (L1 to L4) was less than or equal -1 and their body mass index between 25 and 30 kg/m2. They will be divided into two groups by randomization. 35 postmenopausal women in Group (A) will undergo three weekly sessions of UV therapy in addition to routine aerobic activity and vitamin D supplements (800 IU) daily for three months. For three months, group (B), which consists of 35 postmenopausal women, will undergo daily aerobic exercise and vitamin D supplementation (800 IU) only. The amount of serum 25-hydroxyvitamin D was measured using ELISA kits, bone mineral density of lumber spine was measured by dual energy X-ray absorptiometry (DEXA), and the torque of knee flexors and extensors was evaluated using the Biodex System 3 isokinetic dynamometer,

NCT ID: NCT05347082 Completed - Clinical trials for Postmenopausal Osteoporosis

Frequency of Hyperparathyroidism in Postmenopausal Osteoporosis and Its Treatment

Start date: April 29, 2021
Phase: N/A
Study type: Interventional

Recently, an increase in the prevalence of hyperparathyroidism and hypovitaminosis D in postmenopause women has been occurring in Mexico and the world. Chronic exposure to the parathyroid hormone (PTH) is catabolic for the bone, worsening the state of osteoporosis. However, it is unclear whether these conditions could significantly improve bone mineral density (BMD). In the present work, it was shown that the resolution of hyperparathyroidism in postmenopausal women improves osteoporosis.

NCT ID: NCT05346419 Completed - Clinical trials for Postmenopausal Osteoporosis

Antiresorptive Effect of Treatment With Risedronate and Vitamin D in Postmenopausal Patients

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Osteoporosis is defined as a systemic disease of bone mineralization, characterized by a decrease in bone mineral density that causes bone fragility and increases the risk of fractures during menopause. Recently, a high prevalence of hypovitaminosis D has been found worldwide, which could trigger a state of secondary hyperparathyroidism that can worsen the state of postmenopausal patients with osteoporosis. An open-label, clinical trial was conducted in Mexican women with postmenopausal osteopenia-osteoporosis to determine the efficacy of the combined treatment with risedronate and high-dose vitamin D in improving bone mineral density, hyperparathyroidism, and hypovitaminosis D.

NCT ID: NCT05087030 Completed - Clinical trials for Postmenopausal Osteoporosis

Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis

Start date: September 21, 2021
Phase: Phase 3
Study type: Interventional

This study will be conducted to assess the efficacy, pharmacodynamic (PD), safety, tolerability, and immunogenicity of RGB -14- P compared to US-licensed Prolia® in participants with postmenopausal osteoporosis, in a comparative manner.

NCT ID: NCT04934072 Completed - Clinical trials for Postmenopausal Osteoporosis

A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis

Start date: July 5, 2021
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to demonstrate equivalent efficacy of FKS518 to US-licensed Prolia in women with postmenopausal osteoporosis (PMO). Participants will be randomized at the beginning of the Double-blind Core Treatment Period (Baseline to Week 52) to receive either FKS518 or US-licensed Prolia on Day 1, and then every 26 weeks for up to 52 weeks. At the beginning of the Double-blind Transition Period (Week 52 to Week 78), participants who received US-licensed Prolia will be re-randomized to either continue receiving US-licensed Prolia every 26 weeks for up to 78 weeks, or switch to receive FKS518 every 26 weeks for up to 78 weeks. Participants who were randomized to receive FKS518 at the beginning of the Double-blind Core Treatment Period will continue to receive this treatment during the Double-blind Transition Period. For Marketing Authorization Application (MAA) in the EU and European Economic Area (EEA) only: The primary objective is to demonstrate equivalent efficacy and pharmacodynamics of the proposed biosimilar denosumab FKS518 to US-Prolia in women with PMO.

NCT ID: NCT04873960 Completed - Quality of Life Clinical Trials

Translation and Cross -Cultural Validation of ECOS-16 Questionnaire in Urdu Language

Start date: March 15, 2021
Phase:
Study type: Observational

Osteopenia is a clinical term to define the declined Bone Mineral Density (BMD) as per the normal reference values but not low enough to meet osteoporotic diagnostic criteria. A Dual-energy x-ray absorptiometry (DXA) bone scan is used to diagnose decreased BMD. Osteopenia is, as described by the World Health Organization (WHO), a score ranging from -1 to -2.5, whereas Osteoporosis is diagnosed with values less than - 2.5. The risk of a decrease in BMD doubles as a woman goes into Menopause. The objective of this study will be to determine the effects of Kinect-based virtual reality training on BMD, fracture risk, physical function and Quality of life in postmenopausal women with Osteopenia. The aim of the present study is to translate the ECOS-16 Questionnaire into Urdu Language along with validation of the translated versions by evaluating its validity and reliability in the Postmenopausal women of Pakistan with Osteopenia or Osteoporosis and understanding Urdu Language. No such study has been previously conducted in the Pakistan region which translates the specific questionnaire and follows the proper cross-culture adaptation protocol.

NCT ID: NCT04747392 Completed - Clinical trials for Postmenopausal Osteoporosis

Bioequivalence Study of SAL001 and FORSTEO in Healthy Chinese Adults

Start date: August 19, 2020
Phase: Phase 1
Study type: Interventional

This is a single-center, randomized, open label, single-dose, the original drug controlled, crossover design, two sequence, two periods, Phase Ⅰclinical study. 64 qualified subjects will be randomly assigned to two administration sequences (sequence A and sequence B) at the ratio of 1∶1, with 32 subjects in each sequence. Each period will be given subcutaneous injection once, and the washout period will be 72 hours, and each subject will be given subcutaneous injection twice. Sequence A: the test drug (SAL001) is injected in the first period, and the reference drug (FORSTEO) is injected in the second period. Sequence B: the reference drug (FORSTEO) is injected in the first period, and the test drug (SAL001) is injected in the second period. If the geometric mean ratio (GMR) 90% confidence interval of the major pharmacokinetic indexes (AUC0-t, Cmax) for SAL001 and FORSTEO is between 80.00% and 125.00%, the two drugs are considered to be bioequivalent.

NCT ID: NCT04702204 Completed - Clinical trials for Postmenopausal Osteoporosis

Efficacy of Denosumab Treatment in Bisphosphonate Unresponsive Patients

Start date: July 1, 2020
Phase:
Study type: Observational

This study, which was designed as a prospective observational study, was planned to enroll 75 female patients with postmenopausal osteoporosis who had been using bisphosphonates for more than two years and did not respond to treatment. 2 doses of denosumab were administered to the patients every 6 months. Bone mineral density of patients were measured with DEXA at the beginning and end of the study. A total of 66 patients completed the study. At the end of the study, there was a significant improvement in the femur and lumbar total bone mineral density of the patients compared to the baseline. However, no statistically significant difference was found in terms of the frequency of new fractures.

NCT ID: NCT04664959 Completed - Clinical trials for Postmenopausal Osteoporosis

A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis

Start date: November 26, 2020
Phase: Phase 3
Study type: Interventional

This is a randomised, double-blind, multicentre study to evaluate the efficacy, safety, PK, PD, and immunogenicity of SB16 compared to Prolia® in postmenopausal women with osteoporosis.