Osteoporosis, Osteoporosis, Postmenopausal
Conditions
Keywords
Bone Turnover Markers, Bone Density, Postmenopausal Osteoporosis, DEXA Scan
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.
Interventions
DRUGAlendronate, 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.
DRUGTeriparatide
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.
Sponsors
Khyber Medical University Peshawar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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."
Intervention model description
Participants are randomly assigned to one of two parallel treatment groups to receive different drug interventions concurrently.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bone Turnover Markers (BTMs) | Baseline, 3 months, and 6 months. | 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. |
| Change in Bone Mineral Density (BMD) | Baseline and 6 months. | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of New Fractures | Through study completion, an average of 6 months. | The number of participants who experience any new fragility fractures during the study period. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORAsma Mehmood, PhD Scholar
Institute of Basic Medical Sciences, Khyber Medical University
STUDY_DIRECTORRubina Nazli, PhD
Institute of Basic Medical Sciences, Khyber Medical University
PRINCIPAL_INVESTIGATORArshad Hussain, M.D Consultant
Northwest General Hospital, Peshawar
PRINCIPAL_INVESTIGATOREhtesham Khan, PhD
InsInstitute of Basic Medical Sciences, Khyber Medical University
Outcome results
None listed