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Trial · Interventional

CompletedNot applicableRegistry data

Bone Turnover Markers and Treatment Efficacy in Postmenopausal Osteoporosis

NCTNCT07242612 (opens ClinicalTrials.gov in a new tab)Other idKMU/DIR/CTU/2025/008
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
40 participants (actual)
Sponsor
Khyber Medical University Peshawar · Other
Design
Randomized · Double masking
Countries
1 country

Pakistan

Start
1 Oct 2025
Primary completion
25 Mar 2026
Completion
15 Apr 2026
First posted
21 Nov 2025
Last update posted
13 Aug 2026
Conditions
Osteoporosis · Osteoporosis, Postmenopausal

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202520262027
  1. N/A

    Bone Turnover Markers and Treatment Efficacy in Postmenopausal Osteoporosis

    NCT07242612

    1 Oct 2025 to 15 Apr 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Alendronate, Ibandronate; RisedronateDrug
  • TeriparatideDrug

Arms2

  • 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.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change in Bone Turnover Markers (BTMs)

    Time frame · Baseline, 3 months, and 6 months.

    Registry description

    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.

  2. Change in Bone Mineral Density (BMD)

    Time frame · Baseline and 6 months.

    Registry description

    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.

Secondary outcomes(1)

  1. Incidence of New Fractures

    Time frame · Through study completion, an average of 6 months.

    Registry description

    The number of participants who experience any new fragility fractures during the study period.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2020

11 results

Standard Versus Cyclic Teriparatide and Denosumab Treatment for Osteoporosis: A Randomized Trial.

Cosman et al. 2020Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 16

PMID 31419313DOI 10.1002/jbmr.3850PUB-31419313

Rights unknown11 results
Source linkSee results (11)

Eligibility

Who could join, as posted.

Sex
All
Age
from 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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).

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