Health TrialsbyHealthPanel

Bone Turnover Markers and Treatment Efficacy in Postmenopausal Osteoporosis

ConditionsOsteoporosisOsteoporosis, Postmenopausal
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorKhyber Medical University Peshawar

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Anabolic Therapy GroupExperimental treatment 1 intervention
Group B: Antiresorptive Therapy GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 3 months, and 6 months.
2

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.

Time frame
Baseline and 6 months.

Secondary outcomes

1

Incidence of New Fractures

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Khyber Medical University Peshawar

Lead sponsor

Source ClinicalTrials.gov
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