A prospective phase IV studyto evaluate safety and efficacy profile of DenosteRel® in post-menopausal women with osteoporosis

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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.

11.Height, weight or girth that has a potential to preclude accurate DEXA measurements

13.Administration of fluoride (except for dental treatment), or strontium ranelate within last one year

14.Administration of IV bisphosphonate, cumulative use of oral bisphosphonates (= 1 month) within last 6 months; or any use of oral bisphosphonate within last 3 months ( except for the subset of 50 patients who will be enrolled based on treatment failure with bisphosphonate).

15.Administration of any of the following treatments within 6 weeks prior to screening: Anabolic steroid or testosterone, androgen deprivation therapy, parathyroid hormone analogue, calcitonin, calcitriol, vitamin D derivatives (Vitamin D contained in supplements or multivitamins will be permitted) or other bone active drugs including anticonvulsants and heparin

16.Chronic systemic ketoconazole, chronic systemic corticosteroid, ACTH, cinacalcet, aluminium, lithium, protease inhibitors, methotrexate, gonadotropin-releasing hormone agonists within 6 weeks prior to screening

17.History of Rheumatoid arthritis

18.History of malabsorption syndrome or any gastrointestinal disorders associated with malabsorption.

19.Patients who are HIV, HBsAg, HCV test positive.

20.History of alcohol or substance abuse within the last 12-months which the Investigator believes would interfere with understanding or completing the study.

21.History of myocardial infarction or stroke within 6 months prior to enrolment or any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study: uncontrolled hypertension, unstable angina; congestive heart failure (= grade 2), cardiac arrhythmia, clinically significant peripheral vascular disease; uncontrolled diabetes

22.History or presence of any medical or psychiatric condition or disease, physical examination finding, clinical laboratory finding or any other condition that in the opinion of the Investigator, may place the patient at unacceptable risk for study participation or that might affect the interpreta

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate safety profile of DenosteRel® in postmenopausal women patients with <br/ ><br>osteoporosisTimepoint: AE & SAE Will be Captured at Day 1,Day 30 Day 90, Day 180, Day 270 & Withdrawal Visit

Secondary Outcome Measures

Name	Time	Method
To evaluate efficacy profile of DenosteRel® in postmenopausal women patients with <br/ ><br>osteoporosisTimepoint: Percent change in BMD & T-score at lumbar spine & hip from baseline to month <br/ ><br>6 & month 9 <br/ ><br>Percent change in BMD & T-score at distal radius from baseline to month 6 and <br/ ><br>month 9 <br/ ><br>Incidence of vertebral & non-vertebral fractures at month 6 & month 9 <br/ ><br>Immunogenicity (Baseline & month 9)