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Completed
NCT07717788
Therapeutic Prospects of HMG-CoA Reductase Inhibitors, Atorvastatin and Rosuvastatin, in Osteoporotic Patients
Conditions: Osteoporosis, Postmenopausal, Statin Therapy
Sex: Female
Ages: 55 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 65
Sponsor: Alkufa university\\collage of pharmacy
Location: AL-KUFA UNIVERSITY/College of Pharmacy Najaf
Summary
Osteoporosis is one of the most common chronic skeletal disorders, particularly among postmenopausal women, and is associated with an increased risk of fragility fractures, disability, and reduced quality of life. Several preclinical studies and retrospective clinical studies have suggested that statins may exert beneficial effects on bone metabolism by promoting bone formation and reducing bone resorption. Since osteoporosis and hyperlipidemia frequently coexist in postmenopausal women, the concomitant use of statins with standard osteoporosis therapy may provide dual clinical benefits by improving both skeletal and cardiovascular outcomes. In this prospective interventional study, atorvastatin and Rosuvastatin was administered according to current clinical practice guidelines only to participants with an indication for statin therapy, defined as an atherosclerotic cardiovascular disease (ASCVD) risk score of ≥5%. The effects of standard osteoporosis therapy alone (alendronate, calcium, and vitamin D) were compared with those of standard therapy plus atorvastatin and compared with those of standard therapy plus rosuvastatin. The study aims to evaluate the effect of adjunctive statin therapy on bone mineral density and biochemical markers of bone turnover, including markers of bone formation and bone resorption, in postmenopausal women with osteoporosis.
Eligibility Criteria
Inclusion Criteria:
* patients aged ≥ 55 diagnosed with primary age-related osteoporosis according to European guidance osteoporosis, T-score ≤-2.5, and did not receive any treatment for osteoporosis previously or statins.
Exclusion Criteria:
* patients who had been taking antiresorptive, bone forming or statins, patients who were taking any medications that can affect osteoporosis. Patients who had medical issues that could be a secondary cause for osteoporosis. and patients who were allergic to alendronate or statins were excluded from the study.
Source: ClinicalTrials.gov (NCT07717788). StuddyBuddy aggregates publicly available trial information.