Postmenopausal women with severe osteoporosis
Conditions
Interventions
Trade Name: Aclasta 5 mg solution for infusion
Pharmaceutical Form: Solution for infusion
Current Sponsor code: Aclasta
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Female, between 45 and 89 years of age. Postmenopausal status is according to the following guidelines: (a) cessation of menses for 18 months in women =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Any prior use of strontium. • Calculated creatinine clearance < 30 mL/min. • Urine dipstick greater than/similar to 2+ protein at Visit 2 without evidence of contamination or bacteriuria. • Prior treatment with oral or i.v. bisphosphonates longer than 3 months consecutively. If bisphosphonate exposure is less than or equal than 3 months, a washout period of 1 year prior to randomiztion is required. • Serum calcium greater than or similar to 2.75 mmol/L or = 2.0 mmol/L. • 25(OH) vitamin D levels less than 20 ng/ml prior to randomization. • AST or ALT greater than 3 times the upper limit of normal. • Serum alkaline phosphatase (SAP) greater than 1.5 times the upper limit of normal. • Non-osteoporotic forms of metabolic bone disease, such as and not limited to, Paget’s disease of bone, osteomalacia, osteogenesis imperfecta or multiple myeloma. • Less than 3 evaluable lumbar (L1-L4) vertebrae. • Treatment with SERMs (i.e. raloxifene), calcitonin or HRT within 3 months of randomization. • Allergy or previous exposure to teriparatide. • Previous exposure to exogenous PTH or PTH analogs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate that combination therapy with once yearly i.v. zoledronic acid and daily subcutaneous injections of teriparatide is non-inferior to teriparatide treatment alone with respect to percentage increase in lumbar spine BMD at 52 weeks. If the non-inferiority is established, the superiority of the combination therapy is to be evaluated. ;Secondary Objective: The secondary objectives are: • To evaluate the effect of combination therapy with zoledronic acid and teriparatide compared to teriparatide alone on percent change in total hip BMD at 52 weeks. • To evaluate the effect of combination therapy with zoledronic acid and teriparatide compared to teriparatide alone on percent change of lumbar spine and total hip BMD at 13 and 26 weeks. • To evaluate the effect of combination therapy with zoledronic acid and teriparatide compared to zoledronic acid alone on percent change in lumbar spine and total hip BMD at 13, 26 and 52 weeks. • To evaluate the effect of combination therapy with zoledronic acid and teriparatide compared to teriparatide alone and zoledronic acid alone on serum biochemical markers (P1NP and ß-CTx) at 4, 8, 26, 39 and 52 weeks. ;Primary end point(s): To demonstrate that combination therapy with once yearly i.v. zoledronic acid (5 mg) and daily subcutaneous injections of teriparatide (20 micro gram) is non-inferior to teriparatide treatment alone with respect to percentage increase in lumbar spine BMD at 52 weeks. If the non-inferiority is established, the superiority of the combination therapy (ZOL+PTH) over teriparatide treatment alone is to be evaluated. | — |
Countries
Belgium, Germany
Outcome results
None listed