Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: denosumab; teriparatide
Intervention description: denosumab: 60 mg SC every 6 months; teriparatide: 20 mcg SC QD
Intervention MeSH terms: Denosumab; Teriparatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 94.0
Sex: Female
Minimum age: 45 Years
Healthy volunteers: No
Keywords: osteoporosis; postmenopausal; denosumab; teriparatide; Forteo®; DXA; Bone Mineral Density; pQCT

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.
    

Eligibility criteria:

        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.