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Osteoporosis, Postmenopausalstatins on BMDNCT07717788

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

A study testing Alendronate 70 mg tablets, Atorvastatin and Rosuvastatin in people with Osteoporosis, Postmenopausal and Statin Therapy, run by Alkufa university\\collage of pharmacy at 1 site in Iraq.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and older, women only
Conditions the study is for
Osteoporosis, Postmenopausal, Statin Therapy
What is being tested?
Alendronate 70 mg tablets, Atorvastatin and Rosuvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteIraq
Study dates
1 Feb 2025to 1 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Iraq1 site
  • AL-KUFA UNIVERSITY/College of Pharmacy

    Najaf

Other trials in Iraq

About this study

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.

Read the detailed description

Osteoporosis is a major public health problem, particularly among postmenopausal women, and is characterized by reduced bone mineral density (BMD) and deterioration of bone microarchitecture, leading to an increased risk of fragility fractures. Hyperlipidemia frequently coexists with osteoporosis in this population because both conditions share several risk factors, including aging and menopause. Experimental studies and retrospective clinical studies have suggested that statins may exert favorable effects on bone metabolism by enhancing osteoblast activity, suppressing osteoclast-mediated bone resorption, and promoting bone formation. These findings raise the possibility that statins may provide additional skeletal benefits when administered in combination with standard anti-osteoporotic therapy.

The present prospective interventional study was designed to evaluate the effect of adjunctive statin therapy on bone health in postmenopausal women with osteoporosis. In addition to assessing the overall effect of statins, the study aimed to compare the skeletal effects of two statins with different physicochemical properties: atorvastatin, a lipophilic statin, and rosuvastatin, a hydrophilic statin. The study also investigated whether combining statins with standard osteoporosis therapy provides greater improvement in bone mineral density and bone turnover markers than standard osteoporosis therapy alone. Furthermore, the study evaluated the relationship between changes in lipid profile parameters and improvements in bone mineral density in order to determine whether lipid lowering is associated with skeletal response.

The study protocol was reviewed and approved by the Ethics Committee of the College of Medicine, University of Kufa, and the required administrative and regulatory approvals were obtained from the Iraqi Ministry of Health through the Najaf Health Directorate before study initiation. All participants were informed about study objectives, procedures, potential benefits and possible risks before study initiation. All therapeutic interventions were performed in accordance with current clinical practice guidelines. Statin therapy was prescribed only for participants with a guideline-based clinical indication for treatment (ASCVD risk ≥5%), and no participant received statin therapy solely for research purposes.

Participants were allocated into three study groups according to their estimated 10-year atherosclerotic cardiovascular disease (ASCVD) risk and clinical indication for statin therapy. Women with an ASCVD risk of less than 5%, who had no guideline-based indication for statin treatment, received standard osteoporosis therapy consisting of alendronate, calcium, and vitamin D. Women with an ASCVD risk of 5% or greater, for whom statin therapy was clinically indicated according to current treatment guidelines, received standard osteoporosis therapy plus statin treatment. Participants in this category were randomly assigned to receive either atorvastatin or rosuvastatin in addition to alendronate, calcium, and vitamin D.

Eligible participants were postmenopausal women diagnosed with osteoporosis, defined by a lumbar spine T-score of -2.5 or lower on dual-energy X-ray absorptiometry (DXA). Before treatment initiation, all participants underwent baseline clinical assessment, DXA measurement of bone mineral density, and blood sample collection. Laboratory investigations included lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides), serum calcium, vitamin D, osteocalcin, bone-specific alkaline phosphatase (BALP), C-terminal telopeptide of type I collagen (CTX-1), and bone sialoprotein (BSP).

Participants were followed for six months, during which treatment adherence was monitored. At the end of the follow-up period, DXA measurements and laboratory investigations were repeated using the same assessment methods. Changes in bone mineral density, bone turnover markers, calcium, vitamin D, and lipid profile were compared within each treatment group and between groups. The primary objective was to determine whether the addition of statin therapy to standard osteoporosis treatment resulted in greater improvement in bone mineral density than standard therapy alone. Secondary objectives included comparing the skeletal effects of lipophilic and hydrophilic statins and evaluating the association between improvements in lipid profile and changes in bone mineral density and biochemical markers of bone turnover.

Being tested
Alendronate 70 mg tablets, Atorvastatin, Rosuvastatin
Keywords
Postmenopausal osteoporosis; statin; alendronate; bone mineral density; bone turnover markers.
Medical subject headings
Osteoporosis, Postmenopausal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alendronate 70 mg tabletsDrug

    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.

  • AtorvastatinDrug

    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

  • RosuvastatinDrug

    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

Study groups in NCT07717788
Study groupRoleWhat they receive
standard osteoporosis therapayActive comparatorParticipants 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.
Receives: Drug: Alendronate 70 mg tablets
Atorvastatin Plus Standard osteoporosis therapyExperimentalParticipants with a 10-year ASCVD risk ≥5% and osteoporosis received atorvastatin in addition to standard osteoporosis therapy (alendronate, calcium, and vitamin D).
Receives: Drug: Alendronate 70 mg tablets; Drug: Atorvastatin
rosuvastatin plus standard osteoporosis therapyExperimentalParticipants with a 10-year ASCVD risk ≥5% and osteoporosis received rosuvastatin in addition to standard osteoporosis therapy (alendronate, calcium, and vitamin D).
Receives: Drug: Alendronate 70 mg tablets; Drug: Rosuvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: base line and after 6 months

  2. 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.

    Measured: baseline and 6 months

  3. 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.

    Measured: Baseline and after 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2026
  2. Study start1 Feb 2025
  3. Primary completion1 Jul 2026
  4. Study completion1 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07717788
Sponsor's protocol ID
KU-OP-2025-001
Acronym
statins on BMD
Status last verified
Jul 2026
First submitted
16 Jul 2026
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared because of participant confidentiality and institutional restrictions on data sharing.

Questions about this trial

What is this clinical trial studying?

A study testing Alendronate 70 mg tablets, Atorvastatin and Rosuvastatin in people with Osteoporosis, Postmenopausal and Statin Therapy, run by Alkufa university\\collage of pharmacy at 1 site in Iraq.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in bone mineral density (lumbar spine and hip) (time frame: base line and after 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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