Bone Turnover Markers and Treatment Efficacy in Postmenopausal Osteoporosis

November 17, 2025 updated by: Khyber Medical University Peshawar

Determination of Selective Bone Turnover Markers and Their Association With Treatment Efficacy in Primary Postmenopausal Osteoporotic Women: A Randomized Control Trial

This study investigates the use of blood tests known as Bone Turnover Markers (BTMs) to quickly monitor the effectiveness of osteoporosis treatment in postmenopausal women. Osteoporosis, which weakens bones and increases fracture risk, is typically monitored using a DEXA scan to measure bone density (BMD), but this method changes slowly. BTMs may show a response to medication within just 3 to 6 months. In this randomized controlled trial, 40 postmenopausal women with osteoporosis will be assigned to receive either antiresorptive drugs (which slow bone loss) or anabolic drugs (which build new bone), along with calcium and vitamin D. The study will compare how these treatments affect BTMs and BMD over six months to determine if BTMs can serve as an early and reliable indicator of treatment success, which could be particularly useful in regions like Pakistan where access to repeated DEXA scans is limited.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A randomized controlled trial will be conducted to evaluate the association between selective BTM and the efficacy of different drug therapies in primary postmenopausal osteoporotic women. The study is motivated by the high prevalence of osteoporosis in this demographic in Pakistan and the limitations of the current gold standard, BMD measured by DEXA scan, which reflects changes in bone strength at a delayed rate. BTMs, being biochemical indicators of bone formation and resorption, offer a dynamic and rapid assessment of bone metabolic activity, potentially providing an early measure of treatment response within months rather than years. The trial will enroll 40 eligible women over 50, who will be randomly and blindly assigned to one of two treatment groups: one receiving antiresorptive drugs (such as Alendronate) and the other receiving anabolic drugs (Teriparatide), both supplemented with calcium and vitamin D for a six-month period. The primary outcomes include the comparative change in specific BTMs (BsALP, TRACP-5b, and Sclerostin) at three and six months, and the change in BMD at six months. Secondary outcomes will assess the correlation between BTM and BMD changes, as well as fracture incidence and quality of life. By analyzing these parameters, the study aims to generate valuable evidence for the utility of BTMs in guiding and monitoring osteoporosis treatment in a Pakistani clinical setting, potentially leading to more responsive and personalized patient management.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Khyber Pakhtunkhwa
      • Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Postmenopausal women (at least one year since last menstrual cycle).
  • Age greater than 50 years.
  • Diagnosis of primary osteoporosis.
  • Currently not on any anti-osteoporosis medications.
  • Not taking Calcium or Vitamin D supplements.
  • Volunteer to participate and provide informed consent.

Exclusion Criteria:

  • Women with multiple vertebral fractures or severe lumbar degenerative changes.
  • Use of hormone/estrogen therapy, calcitonin, oral bisphosphonates, IV ibandronate, IV Zoledronic acid, denosumab, or teriparatide within the past 18 months.
  • Use of corticosteroids (short or long-term).
  • History of hyperthyroidism, hypothyroidism, liver disease, kidney disease, or tumors.
  • Presence of secondary causes of osteoporosis (e.g., eating disorders, celiac disease, diabetes, hematologic disorders).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anabolic Therapy Group
Participants in this group will receive the anabolic drug Teriparatide 20 mcg, administered as a daily subcutaneous injection, for a duration of 6 months. In addition, all participants in this arm will receive daily Calcium and Vitamin D supplements.
Drug: Teriparatide
A solution for subcutaneous injection. The dosage is 20 micrograms (mcg) injected once daily. This is combined with daily Calcium and Vitamin D supplementation. The total treatment duration is 6 months.
Other Names:
  • Forteo
Active Comparator: Antiresorptive Therapy Group
Participants will receive one of the following oral antiresorptive drugs for 6 months: Alendronate 70mg weekly, Ibandronate 150mg monthly, or Risedronate 150mg monthly. All participants will also receive Calcium and Vitamin D supplementation.
Drug: Alendronate, Ibandronate; Risedronate
Oral bisphosphonate tablets. Participants will receive one of the following specific regimens: Alendronate 70mg taken once per week, Ibandronate 150mg taken once per month, or Risedronate 150mg taken once per month. This is combined with daily Calcium and Vitamin D supplementation. The total treatment duration is 6 months.
Other Names:
  • Fosamax; Bonviva; Actonel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Bone Turnover Markers (BTMs)
Time Frame: Baseline, 3 months, and 6 months.
Mean change from baseline in the serum levels of specific bone turnover markers, including the bone formation marker Bone-Specific Alkaline Phosphatase (BsALP) and the bone resorption marker Tartrate-Resistant Acid Phosphatase 5b (TRACP-5b), and the osteocyte marker Sclerostin.
Baseline, 3 months, and 6 months.
Change in Bone Mineral Density (BMD)
Time Frame: Baseline and 6 months.
Mean change from baseline in Bone Mineral Density (BMD) T-score as measured by Dual-Energy X-ray Absorptiometry (DEXA) scans at the hip, spine, and femoral neck.
Baseline and 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of New Fractures
Time Frame: Through study completion, an average of 6 months.
The number of participants who experience any new fragility fractures during the study period.
Through study completion, an average of 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khyber Medical University Peshawar

Investigators

  • Principal Investigator: Asma Mehmood, PhD Scholar, Institute of Basic Medical Sciences, Khyber Medical University
  • Study Director: Rubina Nazli, PhD, Institute of Basic Medical Sciences, Khyber Medical University
  • Principal Investigator: Arshad Hussain, M.D Consultant, Northwest General Hospital, Peshawar
  • Principal Investigator: Ehtesham Khan, PhD, InsInstitute of Basic Medical Sciences, Khyber Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

March 25, 2026

Study Completion (Estimated)

April 15, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMU/DIR/CTU/2025/008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A definitive plan for sharing individual participant data has not been established. The data collected, including de-identified individual participant records for primary and secondary outcomes, may be made available upon reasonable request after the primary results are published.

IPD Sharing Time Frame

Data may become available beginning 6 months after the publication of the primary study findings and will be accessible for a period of 3 years.

IPD Sharing Access Criteria

Access to IPD will be considered for researchers who provide a methodologically sound proposal. Requests should be directed to the corresponding author. Approval will be subject to review by the study's supervisory committee and a signed data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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