A study to assess the efficacy and safety of Nandrolone decanoate and alendronate as compared to alendronate alone in patients with disease in which bones are very fragile

Not Applicable

Completed

• Conditions: Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue

• Registration Number: CTRI/2019/08/020843
• Lead Sponsor: Stavya Spine Hospital Research Institute Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-08-26
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 230

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

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 � 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference from baseline in BMD/T score (DXA) ward�s triangle, one vertebra femoral neck, hip, greater trochanter, distal 1/3rd radius <br/ ><br>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 Outcome Measures

Name	Time	Method
Difference from baseline Lean body (muscle) mass and fat mass using DXA <br/ ><br>Change from baseline in the intensity of bone pain (VAS) <br/ ><br>Change from baseline quality of life score <br/ ><br>Change from baseline Oswestry low back pain <br/ ><br>Timepoint: 0,6,12 months