Using blood tests to monitor osteoporosis treatment in postmenopausal women
Determination of Selective Bone Turnover Markers and Their Association With Treatment Efficacy in Primary Postmenopausal Osteoporotic Women: A Randomized Control Trial
This will test whether blood tests called bone turnover markers can quickly show if osteoporosis medicines are working in postmenopausal women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Khyber Medical University Peshawar Academic / other |
| Drugs / interventions | denosumab |
| Locations | 1 site (Peshawar, Khyber Pakhtunkhwa) |
| Trial ID | NCT07242612 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled trial enrolling 40 postmenopausal women with primary osteoporosis at Northwest General Hospital, Peshawar. Participants will be randomly assigned to receive antiresorptive therapy (oral bisphosphonates) or anabolic therapy (teriparatide) with calcium and vitamin D for six months. The study will measure specific bone turnover markers (BsALP, TRACP-5b, and sclerostin) at three and six months and compare those changes with bone mineral density measured by DEXA at six months. Secondary outcomes include the correlation between BTM and BMD changes, fracture incidence, and quality of life measures.
Who should consider this trial
Good fit: Postmenopausal women over age 50 with primary osteoporosis who are not currently on osteoporosis medications or calcium/vitamin D supplements and who can give informed consent are ideal candidates.
Not a fit: Patients with secondary causes of osteoporosis, recent use of bisphosphonates or teriparatide, significant comorbid liver/kidney/thyroid disease, or multiple vertebral fractures are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, patients could get faster feedback from a simple blood test about whether their osteoporosis treatment is working, allowing quicker treatment changes and less reliance on repeated DEXA scans.
How similar studies have performed: Previous research has shown that bone turnover markers change earlier than BMD after treatment, but they are not yet universally accepted as complete substitutes for DEXA or hard fracture outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Peshawar, Khyber Pakhtunkhwa
- Northwest General Hospital — Peshawar, Khyber Pakhtunkhwa, Pakistan (Recruiting)
Study contacts
- Principal investigator: Asma Mehmood, PhD Scholar — Institute of Basic Medical Sciences, Khyber Medical University
- Study coordinator: Asma Mehmood, PhDScholar
- Email: asma13mehmood@gmail.com
- Phone: 0333-9400179
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.