Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis (DATA)

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Osteoporosis

Treatments: Drug: teriparatide; Drug: denosumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00926380

20080723

2009P000525

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 3 patient groups

denosumab ONLY

Experimental group

Treatment:

Drug: denosumab

teriparatide (Forteo®) ONLY

Experimental group

Treatment:

Drug: teriparatide

denosumab and teriparatide (Forteo®)

Experimental group

Treatment:

Drug: denosumab

Drug: teriparatide