Health Condition 1: M859- Disorder of bone density and structure, unspecified Health Condition 2: E559- Vitamin D deficiency, unspecified
Conditions
Interventions
Intervention1: NIL: NIL
Intervention2: Nil: Nil
Sponsors
Stavya Spine Hospital and Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: Ambulatory patients Patients with BMD value consistent with a T-score between ? -2.5 at either Wardâ??s triangle or lumbar spine or greater trochanter or distal1/3rd radius Written informed consent from the patient Patient literate willing to comply with the protocol requirements
Exclusion criteria
Exclusion criteria: History of hypersensitivity to nandrolone or alendronate or any of its excipients Patients with any metabolic bone diseases such as but not limited to osteomalacia or osteogenesis imperfecta, Pagetâ??s disease, Cushingâ??s disease or Hyperprolactinemia Patients with any malignancy Patients with severe, untreated hypercalcemia or hypocalcaemia Uncontrolled hyperthyroidism or hypothyroidism except patients on stable thyroid hormone replacement therapy for last one year History of hyperparathyroidism History of any surgery within 3 months Administration of bone metabolism drugs within last 6 weeks: Anabolic steroids or testosterone Parathyroid hormone (PTH) or PTH derivatives, e.g., teriparatide Glucocorticosteroids (5 mg prednisone equivalent per day for more than 10 days) Systemic hormone replacement therapy Selective estrogen receptor modulators (SERMs), e.g., raloxifene Tibolone Calcitonin Anticonvulsants (except benzodiazepines) Chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, gonadotropin-releasing hormone agonists Received any solid organ or bone marrow transplant or on chronic immunosuppression for any reason Patients with hepatic dysfunction (serum transaminases ? 3 x ULN, alkaline phosphatase or bilirubin ? 2 x ULN) or renal dysfunction (serum creatinine ? 2 mg/dl) Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy Known to have tested positive for human immunodeficiency virus (HIV), HCV or HBsAg Participation in another clinical trial in the past 3 months History of alcohol or drug abuse Any other reason for which the investigator feels that patient should not participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference from baseline in BMD/T score (DXA) wardâ??s triangle, one vertebra femoral neck, hip, greater trochanter, distal 1/3rd radiusTimepoint: 0 month,6 months and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference from baseline Lean body (muscle) mass and fat mass using DXATimepoint: 0,6,12 months | — |
Countries
India
Contacts
Public ContactDr Bharat R Dave
Stavya Spine Hospital And Research Institute
Outcome results
None listed