Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue
Conditions
Interventions
Intervention1: nandrolone decanoate, alendronate: patients will be randomised to receive nandrolone decanoate and alendronate.
Deca Durabolin (Nandrolone Decanoate) 50mg i.m. every 3 weeks for 12 week
Sponsors
Stavya Spine Hospital Research Institute Trust
Eligibility
Inclusion criteria
Inclusion criteria: Ambulatory patients Patients with BMD value consistent with a T-score between ââ?°Â¤ -2.5 at either Wardââ?¬•s triangle or lumbar spine or greater trochanter or distal 1/3rd 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, Pagetââ?¬•s disease, Cushingââ?¬•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 ââ?°Â¥ 3 x ULN, alkaline phosphatase or bilirubin ââ?°Â¥ 2 x ULN) or renal dysfunction (serum creatinine ââ?°Â¥ 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) wardââ?¬â?¢s triangle, one vertebra femoral neck, hip, greater trochanter, distal 1/3rd radius Timepoint: Visit 1 Screening Visits ( Up to 2 weeks), Visit 2 BaseLine (Day 0), Visit 3 Follow up (Week 24),Visit 4 Week 48) End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference from baseline Lean body (muscle) mass and fat mass using DXA Change from baseline in the intensity of bone pain (VAS) Change from baseline quality of life score Change from baseline Oswestry low back pain Timepoint: 0,6,12 months | — |
Countries
India
Contacts
Public ContactDr Bharat Dave
Stavya Spine Hospital & Research Institute Annexe
Outcome results
None listed