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Postmenopausal Osteoporosis clinical trials

View clinical trials related to Postmenopausal Osteoporosis.

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NCT ID: NCT04719650 Not yet recruiting - Clinical trials for Postmenopausal Osteoporosis

Clinical Pharmacokinetics and Pharmacodynamics Study of Different Doses of Zoledronic Acid

Start date: October 2021
Phase: Phase 4
Study type: Interventional

The recommended dosing regimen of zoledronic acid in Chinese osteoporosis patients is completely in accordance with the one of 5 mg per year abroad that based on the dosing regimen in Paget's disease. This dosing regimen lacks the actual supportive clinical data of Chinese patients. In addition, the overall incidence of acute phase response, the main adverse event after the first infusion, in Chinese patients is higher than that in Caucasian patients population. Moreover, the results of the similar drug clinical study in the Japanese patients shown that the purpose of effective treatment for osteoporosis could be achieved with half of the dosage in Caucasian population. Thus, it could be inferred from these that the dosing regimen of zoledronic acid might be inappropriate in Chinese osteoporosis patients. Therefore, the main purpose of this clinical trail is to compare the zoledronic acid pharmacokinetic and pharmacodynamic characteristic of different doses in Chinese postmenopausal subjects with low bone mass or osteoporosis and explore the best dosing regimen in Chinese patients.

NCT ID: NCT04719481 Not yet recruiting - Clinical trials for Postmenopausal Osteoporosis

Pravastatin Reduces Acute Phase Response of Zoledronic Acid

Start date: November 2021
Phase: Phase 4
Study type: Interventional

Acute phase response (APR) is one of the most common adverse events in osteoporosis with zoledronic acid treatment. It's reported that this reaction is related to the blockade of the mevalonate pathway, leading to isopentenyl pyrophosphate (IPP) accumulation. And the latter can active γδT cells in the circulation, resulting in inflammatory cytokine release. Statins can inhibit the conversion of HMG-CoA to mevalonate that may reduce the accumulation of IPP. Therefore, it is possible that statins can be taken in advance to reduce APR caused by zoledronic acid infusion.

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.

NCT ID: NCT04653350 Completed - Clinical trials for Postmenopausal Osteoporosis

High Intensity Multi-Modal Exercise Training in Postmenopausal Women

HIT-MMEX
Start date: November 1, 2020
Phase: N/A
Study type: Interventional

in Pakistan 9.9 million people are osteoporotic and 7.2 million amongst them are women. Globally after every 3 seconds there is occurrence of fragility fracture.In Pakistan females carries different risk factors based on distinct culture, environment, diet and lifestyle. So there is dire need to conduct more high quality clinical trials at National level in order to establish strong evidence in favor of low cost but highly effective exercise protocols for such a significant public health issue.

NCT ID: NCT04591275 Recruiting - Clinical trials for Postmenopausal Osteoporosis

Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia® .

Start date: March 31, 2021
Phase: Phase 3
Study type: Interventional

evaluate the differences in effectiveness and safety between CMAB807( potential biosimilar) and Prolia(original product)

NCT ID: NCT04431960 Completed - Clinical trials for Cardiovascular Diseases

Blackcurrants Modify Gut Microbiota and Reduce Osteoporosis and CVD Risk

Start date: July 20, 2021
Phase: Phase 1
Study type: Interventional

Aim to evaluate the effects of blackcurrant supplementation on changes in gut microbiome, bone mass, and CVD risk factors in adult women.

NCT ID: NCT04366726 Completed - Clinical trials for Postmenopausal Osteoporosis

Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Usability of Abaloparatide-solid Microstructured Transdermal System (sMTS) in Postmenopausal Women With Low Bone Mineral Density (BMD)

Start date: April 9, 2019
Phase: Phase 1
Study type: Interventional

This was an open-label, single-center study to evaluate the usability of abaloparatide-sMTS by participants with low BMD.

NCT ID: NCT04338529 Active, not recruiting - Clinical trials for Postmenopausal Osteoporosis

Alendronate in an Weekly Effervescent Tablet Formulation Following Denosumab Discontinuation

BAD
Start date: April 1, 2020
Phase:
Study type: Observational

Discontinuation of denosumab results in a rebound response of bone turnover markers, which rise above baseline at 3 months and remain elevated until reaching again baseline levels approximately 30 months after the last dose. Bone mineral density (BMD) gains are also lost and BMD values reach original baseline values after 1-2 years off-treatment.For the above reasons, current literature recommends that patients who discontinue denosumab should continue to receive either intravenous (iv) or oral (peros) bisphosphonate therapy for some time. The study aims to investigate changes in the BMD of the lumbar spine 12 months after transitioning from denosumab to oral alendronate 70 mg in a weekly effervescent tablet formulation

NCT ID: NCT04169789 Completed - Clinical trials for Postmenopausal Osteoporosis

Prevention of Early Postmenopausal Bone Loss With Lactobacillus Reuteri

ELBOWII
Start date: December 4, 2019
Phase: N/A
Study type: Interventional

This study evaluates the effect of two different doses of Lactobacillus reuteri ATCC PTA 6475 (L.reuteri 6475) on bone loss in early postmenopausal women. One third of the participants will be randomised to the lower dose, one third to the higher dose and one third to placebo.