Overview

This trial is active, not recruiting.

Condition osteoporosis
Treatments denosumab, teriparatide
Phase phase 2
Sponsor Massachusetts General Hospital
Collaborator Amgen
Start date June 2009
End date December 2016
Trial size 90 participants
Trial identifier NCT00926380, 20080723, 2009P000525

Summary

The aim of this study is to determine whether denosumab (an FDA-approved osteoporosis therapy), in combination with teriparatide (an FDA-approved osteoporosis therapy), will increase bone mineral density more than either one alone in postmenopausal osteoporotic women.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
denosumab
denosumab: 60 mg SC every 6 months
(Experimental)
teriparatide Forteo®
teriparatide: 20 mcg SC QD
(Experimental)
denosumab
denosumab: 60 mg SC every 6 months
teriparatide Forteo®
teriparatide: 20 mcg SC QD

Primary Outcomes

Measure
Bone Mineral Density by Dual X-ray Absorptiometry (DXA)
time frame: 06/2009-02/2015

Eligibility Criteria

Female participants at least 45 years old.

Inclusion Criteria: Must satisfy A and B and C and D below: - (A) Women aged > 55 - (B) Postmenopausal - (C) Osteoporotic with high risk of fracture Exclusion Criteria: - Confirmed serum alkaline phosphatase above upper normal limit with no explanation - Liver disease (AST or ALT > 2 x upper normal limit). - Renal disease (serum creatinine > 2.0 mg/dl). - Hypercalcemia (Ca >10.5 mg/dL) - Elevated blood PTH (intact PTH > 65 pg/ml) - Serum 25-OH vitamin D < 20 ng/ml - HCT < 32%. - History of malignancy (except basal cell carcinoma) or radiation therapy. - Significant cardiopulmonary disease including unstable coronary artery disease, stage D ACC/AHA heart failure or any other condition that the investigator deems may preclude the subject from participating safely or completing the protocol procedures. - Major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures. - Excessive alcohol use or substance abuse that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures. - Known congenital or acquired bone disease other than osteoporosis (including osteomalacia, hyperparathyroidism, Paget's disease) - Current use or use in the past 6 months of oral bisphosphonate - Current use or use within the past 3 months of estrogens, selective estrogen receptor modulators, or calcitonin. - Use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months. - Any current or previous use of strontium or any parenteral bisphosphonate. - Known sensitivity to mammalian cell-derived drug products. - Known sensitivity to teriparatide or any of its excipients.

Additional Information

Official title The Denosumab And Teriparatide Administration Study (DATA)
Principal investigator Benjamin Z Leder, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.