Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis

Phase 2

Completed

• Conditions: Osteoporosis
• Interventions: Drug: denosumab; Drug: teriparatide

• Registration Number: NCT00926380
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-19
• Study First Submitted QC: 2009-06-22
• Study First Posted: 2009-06-23
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Results First Submitted: 2018-03-08
• Results First Submitted QC: 2018-04-06
• Status Verified: 2018-05
• Results First Posted: 2018-05-08
• Last Update Submitted: 2018-05-30
• Last Update Posted: 2018-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 94

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
denosumab ONLY	denosumab	-
teriparatide (Forteo®) ONLY	teriparatide	-
denosumab and teriparatide (Forteo®)	denosumab	-
denosumab and teriparatide (Forteo®)	teriparatide	-

Primary Outcome Measures

Name	Time	Method
Change in Spine Bone Density From Baseline to 2 Years	Baseline and 2 years

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States