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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Pakistan
Northwest General Hospital
RECRUITING
Peshawar
Contact Information
Primary
Asma Mehmood, PhDScholar
asma13mehmood@gmail.com
0333-9400179
Backup
Rubina Nazli, PhD (Professor)
rubinanazli44@gmail.com
0321-5773696
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2026-04-15
Participants
Target number of participants: 40
Treatments
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.
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.
Sponsors
Leads: Khyber Medical University Peshawar

This content was sourced from clinicaltrials.gov