Bone Turnover Markers and Treatment Efficacy in Postmenopausal Osteoporosis

NCT ID: NCT07242612

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-04-15

Brief 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.

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.

Conditions

Osteoporosis; Osteoporosis, Postmenopausal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Teriparatide

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Alendronate, Ibandronate; Risedronate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Fosamax; Bonviva; Actonel; Forteo

Eligibility 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).

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Khyber Medical University Peshawar

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Asma Mehmood, PhD Scholar

Role: PRINCIPAL_INVESTIGATOR

Institute of Basic Medical Sciences, Khyber Medical University

Rubina Nazli, PhD

Role: STUDY_DIRECTOR

Institute of Basic Medical Sciences, Khyber Medical University

Arshad Hussain, M.D Consultant

Role: PRINCIPAL_INVESTIGATOR

Northwest General Hospital, Peshawar

Ehtesham Khan, PhD

Role: PRINCIPAL_INVESTIGATOR

InsInstitute of Basic Medical Sciences, Khyber Medical University

Locations

Northwest General Hospital

Peshawar, Khyber Pakhtunkhwa, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Asma Mehmood, PhDScholar

Role: CONTACT

asma13mehmood@gmail.com

0333-9400179

Rubina Nazli, PhD (Professor)

Role: CONTACT

rubinanazli44@gmail.com

0321-5773696

Facility Contacts

Asma Mehmood, PhD Scholar

Role: primary

asma13mehmood@gmail.com

03339400179

Arshad Hussain, PhD

Role: backup

Hussainadr@gmail.com

03312710692

References

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Other Identifiers

KMU/DIR/CTU/2025/008

Identifier Type: -

Identifier Source: org_study_id