Therapeutic Prospects of HMG-CoA Reductase Inhibitors, Atorvastatin and Rosuvastatin, in Osteoporotic Patients

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.

Conditions

• Osteoporosis, Postmenopausal
• Statin Therapy

Interventions

DRUG

Alendronate 70 mg tablets

Before treatment initiation, all participants underwent baseline evaluation, including dual-energy X-ray absorptiometry (DXA) for bone mineral density assessment, measurement of blood pressure, fasting blood glucose, and lipid profile, as well as collection of demographic and clinical data. Blood samples were obtained from all participants, and serum was separated for the assessment of biochemical markers of bone metabolism, including osteocalcin, bone-specific alkaline phosphatase (BALP), C-terminal telopeptide of type I collagen (CTX-1), bone sialoprotein (BSP), serum calcium, and vitamin D concentrations. Participants diagnosed with osteoporosis received standard osteoporosis therapy consisting of alendronate 70 mg administered once weekly, together with calcium carbonate and vitamin D supplementation. Calcium and vitamin D doses were individualized according to each participant's clinical requirements and baseline laboratory findings, in accordance with standard clinical practice.

DRUG

Atorvastatin

Participants diagnosed with osteoporosis and having an estimated 10-year atherosclerotic cardiovascular disease (ASCVD) risk of ≥5%, indicating guideline-based statin therapy, received atorvastatin in addition to standard osteoporosis therapy consisting of alendronate 70 mg administered once weekly, calcium carbonate, and vitamin D supplementation. Atorvastatin was administered once daily at a dose of 20-40 mg, individualized according to each participant's cardiovascular risk assessment and baseline lipid profile, in accordance with current clinical practice guidelines. Calcium and vitamin D doses were also individualized according to each participant's clinical requirements and baseline laboratory findings. Before treatment initiation, all participants underwent baseline evaluation, including dual-energy X-ray absorptiometry (DXA), blood pressure measurement, fasting blood glucose, lipid profile assessment, collection of demographic and clinical data, and blood sampling for serum ana

DRUG

Rosuvastatin

Participants diagnosed with osteoporosis and having an estimated 10-year atherosclerotic cardiovascular disease (ASCVD) risk of ≥5%, indicating guideline-based statin therapy, received rosuvastatin in addition to standard osteoporosis therapy consisting of alendronate 70 mg administered once weekly, calcium carbonate, and vitamin D supplementation. Rosuvastatin was administered once daily at a dose of 10-40 mg, individualized according to each participant's cardiovascular risk assessment and baseline lipid profile, in accordance with current clinical practice guidelines. Calcium and vitamin D doses were also individualized according to each participant's clinical requirements and baseline laboratory findings. Before treatment initiation, all participants underwent baseline evaluation, including dual-energy X-ray absorptiometry (DXA), blood pressure measurement, fasting blood glucose, lipid profile assessment, collection of demographic and clinical data, and blood sampling for serum ana

Sponsors & Collaborators

• Alkufa university\\collage of pharmacy

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

55 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-01

Primary Completion

2026-07-01

Completion

2026-07-01

Countries

• Iraq

Study Locations