An academic clinical study to assess the efficacy and safety of nandrolone decanoate and alendronate compared with alendronate alone in patients with osteoporosis

Abstract

Objective: The purpose of the study was to evaluate the efficacy and safety of therapy with nandrolone decanoate and alendronate compared with alendronate monotherapy in patients with osteoporosis. Materials and Methods: Osteoporotic patients with T scores less than or equal to -2.5 (World Health Organization) either at lumbar vertebrae or hip, fulfilling inclusion criteria were enrolled in the study. Patients were randomized into two groups. Patients in group A were administered injection of Deca Durabolin (nandrolone decanoate) 50-mg intramuscular every 3 weeks for 12 weeks followed by every 4 weeks for the next 36 weeks along with alendronate 70 mg per oral (p.o) every week for 48 weeks. Patients in group B received only alendronate 70 mg (p.o) for 48 weeks. Follow-up was done at 3, 6, and 12 months for clinical evaluation and answering the questionnaire. Results: A total of 230 patients with the mean age of 60 years were enrolled in the study. At the end of 1 year, 53 patients were lost to follow‑up, and 177 patients were included in the study analysis. Enrolled patients were randomized to group A (n = 89) and group B (n = 88). Patients in group A had significantly higher improvement in bone mineral density (BMD) of lumbar spine, frailty score, quality-of-life (QOL) score compared with patients in group B. Patients in both groups had improvement in BMD of hip, lean mass, body fat, Oswestry disability index, and visual analog score but it was not statistically significant on the intergroup comparison. Conclusion: Our results demonstrate that the addition of nandrolone decanoate to alendronate therapy increases lumbar spine BMD. Improvement in bone quality also translates into an improvement in patient-related outcome measures such as QOL and frailty scores.