A clinical phase III trial to study and compare the effects of human Recombinant PTH in post menopausal female with Osteoporosis

Phase 3

Registration Number: CTRI/2009/091/000293

Lead Sponsor: Intas Biopharmaceuticals Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

1.Post menopausal female patients with an age  45 years and least one year since the last menstruation. If a patient?s menopausal status at screening is in question, by history or due to the patient having a hysterectomy without oophorectomy, a follicle-stimulating hormone (FSH) level to be obtained. Patients with an FSH > 40 mIU/mL will satisfy the definition of postmenopausal status.
2.Women who are 45-54 years of age with the following bone mineral density (BMD) and/or vertebral fracture:
BMD 3.0 standard deviations (SDs) or more below peak bone mass of young females at the lumbar spine or
BMD 2.5 SDs or more below peak bone mass of young females at the lumbar spine with the presence of a vertebral fracture
3.Women 55 or more years of age with the following BMD and/or vertebral fracture:
BMD 2.5 SDs or more below peak bone mass of young females at the lumbar spine, or
BMD 2.0 SDs or more below peak bone mass of young females at the lumbar spine with the presence of a vertebral fracture

4.Women who are capable of understanding and giving written, voluntary informed consent before the clinical trial screening visit
5.Patient must be recombinant Human Parathyroid Hormone naive

Exclusion Criteria

1.Male patients
2.Female < 45 years
3.Patients diagnosed with Paget?s disease
4.Prior external beam or implant radiation therapy involving the skeleton
5.Patients with bone metastasis
6.Metabolic bone disease other than Osteoporosis
7.Pre existing hypercalcemia: Serum calcium greater than 10.2 mg/dL (2.55 mmol/L)
8.Hypersensitivity to the product or its constituents
9.Any history or presence of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results
10.Patient who are receiving or will receive and have received in past 30 days any of the following therapy:
?Strontium
?Fluoride
?Calcitonin
?Bisphosphonates
?Anabolic Androgens and steroids
?Estrogen replacement therapy.
?Methotrexate
?Selective estrogen receptor modulators

11.Have received any Investigational product in last 30 days or going to receive any Investigational product during the study period.
12.Patient with confirmatory diagnosis of carcinoma
13.Suspected or confirmed poor compliance, according to investigators judgment, in completing the trial and follow up.