CTRI/2024/03/064638
Recruiting
Phase 4
A prospective, multi-centre, open label, phase IV studyto evaluate safety and efficacy profile of DenosteRel® inpost-menopausal women with osteoporosis - NA
Reliance Life Sciences Pvt Ltd RLS0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: M810- Age-related osteoporosis without current pathological fracture
- Sponsor
- Reliance Life Sciences Pvt Ltd RLS
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Postmenopausal ambulatory woman \=75 years of age (post menopausal phase of 5 years or more).
- •2\.Patients with BMD value consistent with a T\-score between \-2\.5 to \-4\.0 at either lumbar spine or hip.
- •3\.Able to understand the study procedures and the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements.
Exclusion Criteria
- •1\.Patients with any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings, Paget’s disease, Cushing’s disease or Hyperpolactinemia
- •2\.Patients with severe, untreated hypocalcaemia or hypercalcemia
- •3\.Patients with Vitamin D deficiency; Vitamin D supplements will be permitted and patient can be retested for Vitamin D.
- •4\.Current hyperparathyroidism or hypoparathyroidism
- •5\.Uncontrolled Hyperthyroidism or hypothyroidism except patients on stable thyroid hormone replacement therapy for last one year
- •6\.Any clinical fracture within last 6 months prior to screening and/or any vertebral fracture on screening spinal X\-ray
- •7\.Prior use of Denosumab; hypersensitivity to the Denosumab or any of the excipients
- •8\.Patients with prior history or current evidence of osteomyelitis or osteonecrosis of the jaw, active dental or jaw condition which requires oral surgery, planned invasive dental procedure or non\-healed dental or oral surgery.
- •9\.Receivedanysolidorganorbonemarrowtransplantoronchronic immunosuppression for any reason
- •10\.History of malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5\-years.
Outcomes
Primary Outcomes
Not specified
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