Bone Turnover Markers and Treatment Efficacy in Postmenopausal Osteoporosis

NCT07242612 | Recruiting DMC

• 1 other identifier: KMU/DIR/CTU/2025/008
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Osteoporosis, Postmenopausal

Keywords

Bone Turnover Markers; Bone Density; Postmenopausal Osteoporosis; DEXA Scan

Outcome Measures

Primary Outcomes (2)

• Change in Bone Turnover Markers (BTMs)

  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)

  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 Outcomes (1)

• Incidence of New Fractures

  Through study completion, an average of 6 months.

Study Arms (2)

Anabolic Therapy Group

EXPERIMENTAL

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

Antiresorptive Therapy Group

ACTIVE COMPARATOR

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

Interventions

Alendronate, Ibandronate; Risedronate 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.

Also known as: Fosamax; Bonviva; Actonel

Antiresorptive Therapy Group

Teriparatide 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.

Also known as: Forteo

Anabolic Therapy Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead

Study Sites (1)

Northwest General Hospital

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

RECRUITING

Related Publications (8)

• Lorentzon M, Branco J, Brandi ML, Bruyere O, Chapurlat R, Cooper C, Cortet B, Diez-Perez A, Ferrari S, Gasparik A, Herrmann M, Jorgensen NR, Kanis J, Kaufman JM, Laslop A, Locquet M, Matijevic R, McCloskey E, Minisola S, Pikner R, Reginster JY, Rizzoli R, Szulc P, Vlaskovska M, Cavalier E. Algorithm for the Use of Biochemical Markers of Bone Turnover in the Diagnosis, Assessment and Follow-Up of Treatment for Osteoporosis. Adv Ther. 2019 Oct;36(10):2811-2824. doi: 10.1007/s12325-019-01063-9. Epub 2019 Aug 22.

  PMID: 31440982 BACKGROUND

• Bhattoa HP, Cavalier E, Eastell R, Heijboer AC, Jorgensen NR, Makris K, Ulmer CZ, Kanis JA, Cooper C, Silverman SL, Vasikaran SD; IFCC-IOF Committee for Bone Metabolism. Analytical considerations and plans to standardize or harmonize assays for the reference bone turnover markers PINP and beta-CTX in blood. Clin Chim Acta. 2021 Apr;515:16-20. doi: 10.1016/j.cca.2020.12.023. Epub 2020 Dec 28.

  PMID: 33382995 BACKGROUND

• Nadeem S, Pervez A, Abid MA, Khalid RN, Rizvi NA, Aamdani SS, Ayub B, Mustafa MA, Ahmed S, Riaz M, Irfan K, Noordin S, Jafri L, Majid H, Umer M, Zehra N, Sheikh A, Haider AH, Khan AH. GRADE-ADOLOPMENT of clinical practice guideline for postmenopausal osteoporosis management-a Pakistani context. Arch Osteoporos. 2023 May 19;18(1):71. doi: 10.1007/s11657-023-01258-2.

  PMID: 37204537 BACKGROUND

• Jorgensen NR, Mollehave LT, Hansen YBL, Quardon N, Lylloff L, Linneberg A. Comparison of two automated assays of BTM (CTX and P1NP) and reference intervals in a Danish population. Osteoporos Int. 2017 Jul;28(7):2103-2113. doi: 10.1007/s00198-017-4026-z. Epub 2017 Apr 28.

  PMID: 28455749 BACKGROUND

• Moller AMJ, Delaisse JM, Olesen JB, Canto LM, Rogatto SR, Madsen JS, Soe K. Fusion Potential of Human Osteoclasts In Vitro Reflects Age, Menopause, and In Vivo Bone Resorption Levels of Their Donors-A Possible Involvement of DC-STAMP. Int J Mol Sci. 2020 Sep 2;21(17):6368. doi: 10.3390/ijms21176368.

  PMID: 32887359 BACKGROUND

• Patel D, Worley JR, Volgas DA, Crist BD. The Effectiveness of Osteoporosis Screening and Treatment in the Midwest. Geriatr Orthop Surg Rehabil. 2018 Mar 29;9:2151459318765844. doi: 10.1177/2151459318765844. eCollection 2018.

  PMID: 29623238 BACKGROUND

• Rizzoli R. Postmenopausal osteoporosis: Assessment and management. Best Pract Res Clin Endocrinol Metab. 2018 Oct;32(5):739-757. doi: 10.1016/j.beem.2018.09.005. Epub 2018 Sep 22.

  PMID: 30449552 BACKGROUND

• Cosman F, McMahon D, Dempster D, Nieves JW. Standard Versus Cyclic Teriparatide and Denosumab Treatment for Osteoporosis: A Randomized Trial. J Bone Miner Res. 2020 Feb;35(2):219-225. doi: 10.1002/jbmr.3850. Epub 2019 Oct 23.

  PMID: 31419313 BACKGROUND

MeSH Terms

Conditions

Osteoporosis; Osteoporosis, Postmenopausal

Interventions

Alendronate; Ibandronic Acid; Risedronic Acid; Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Asma Mehmood, PhD Scholar

  Institute of Basic Medical Sciences, Khyber Medical University

  PRINCIPAL INVESTIGATOR

• Rubina Nazli, PhD

  Institute of Basic Medical Sciences, Khyber Medical University

  STUDY DIRECTOR

• Arshad Hussain, M.D Consultant

  Northwest General Hospital, Peshawar

  PRINCIPAL INVESTIGATOR

• Ehtesham Khan, PhD

  InsInstitute of Basic Medical Sciences, Khyber Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asma Mehmood, PhDScholar

CONTACT

0333-9400179; asma13mehmood@gmail.com

Rubina Nazli, PhD (Professor)

CONTACT

0321-5773696; rubinanazli44@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The protocol states this will be a "double blinded study" where "the participant and researcher will be unaware of the interventions until the participants complete their 6 months of interventions. Only the research assistant will be aware of the interventions given."
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to one of two parallel treatment groups to receive different drug interventions concurrently.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: October 1, 2025
• Primary Completion: March 25, 2026
• Study Completion: April 15, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

PA (1)