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

NCT07717788 | Completed

• 1 other identifier: KU-OP-2025-001
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Postmenopausal osteoporosis; statin; alendronate; bone mineral density; bone turnover markers.

Outcome Measures

Primary Outcomes (3)

• change in bone mineral density (lumbar spine and hip)

  Bone mineral density (BMD) was assessed at baseline and after 6 months using dual-energy X-ray absorptiometry (DXA). Measurements were obtained at the lumbar spine and left hip, and corresponding T-scores were recorded to evaluate changes in bone density following treatment.

  base line and after 6 months

• change in serum calcium and vitamin D levels

  Blood samples were collected from all participants at baseline and after 6 months of treatment. Serum calcium and vitamin D levels were measured to evaluate changes in bone mineral metabolism following treatment.

  baseline and 6 months

• Change in Serum Bone turnover biomarkers

  Change in serum concentrations of osteocalcin, bone-specific alkaline phosphatase (BSAP), C-terminal telopeptide of type I collagen (CTX-I), and bone sialoprotein (BSP) from baseline to 6 months as indicators of bone formation and bone resorption.

  Baseline and after 6 months

Other Outcomes (1)

• Change in serum lipid profile

  baseline and 6 months

Study Arms (3)

standard osteoporosis therapay

ACTIVE COMPARATOR

Participants with a 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk \<5% and osteoporosis (T-score ≤ -2.5) received standard osteoporosis therapy consisting of alendronate, calcium, and vitamin D.

Drug: Alendronate 70 mg tablets

Atorvastatin Plus Standard osteoporosis therapy

EXPERIMENTAL

Participants with a 10-year ASCVD risk ≥5% and osteoporosis received atorvastatin in addition to standard osteoporosis therapy (alendronate, calcium, and vitamin D).

Drug: Alendronate 70 mg tablets; Drug: Atorvastatin

rosuvastatin plus standard osteoporosis therapy

EXPERIMENTAL

Participants with a 10-year ASCVD risk ≥5% and osteoporosis received rosuvastatin in addition to standard osteoporosis therapy (alendronate, calcium, and vitamin D).

Drug: Alendronate 70 mg tablets; Drug: Rosuvastatin

Interventions

Alendronate 70 mg tablets DRUG

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.

Atorvastatin Plus Standard osteoporosis therapy; rosuvastatin plus standard osteoporosis therapy; standard osteoporosis therapay

Atorvastatin DRUG

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

Atorvastatin Plus Standard osteoporosis therapy

Rosuvastatin DRUG

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

rosuvastatin plus standard osteoporosis therapy

Eligibility Criteria

• Age: 55 Years+
• Gender Eligibility Details: Although the study initially considered adults with osteoporosis regardless of sex, all eligible participants recruited during the enrollment period were women with postmenopausal osteoporosis. Therefore, the final study population consisted exclusively of postmenopausal women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alkufa university\\collage of pharmacy: lead

Study Sites (1)

AL-KUFA UNIVERSITY/College of Pharmacy

Najaf, Iraq

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Alendronate; Atorvastatin; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PH.D. Student

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: February 1, 2025
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)