RECRUITINGINTERVENTIONAL

Bone Turnover Markers and Treatment Efficacy in Postmenopausal Osteoporosis

Determination of Selective Bone Turnover Markers and Their Association With Treatment Efficacy in Primary Postmenopausal Osteoporotic Women: A Randomized Control Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. Who Should NOT Join This Trial: - 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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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).

Treatments Being Tested

DRUG

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.

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.

Locations (1)

Northwest General Hospital

Peshawar, Khyber Pakhtunkhwa, Pakistan