Efficacy of Cinacalcet in the Control of Primary Hyperparathyroidism
NCT02417389 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2015-04-15
Summary
To assess the efficacy and safety of treatment with cinacalcet and with cinacalcet plus alendronate in controlling bone loss induced by primary hyperparathyroidism.
Conditions
- Hyperparathyroidism, Primary
- Osteoporosis
Interventions
- DRUG
-
cinacalcet
During Phase 1 (months 1-12): oral administration; 30 mg twice/day (dose to be increased if needed).
- DRUG
-
Alendronate
During Phase 2 (months 13-24): oral administration; 70 mg once/week (in addition to cinacalcet 30 mg twice/day as during Phase 1).
Sponsors & Collaborators
-
Istituto Auxologico Italiano
lead OTHER
Principal Investigators
-
Maria Luisa BIANCHI, M.D. · Istituto Auxologico Italiano IRCCS
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-05-31
- Primary Completion
- 2011-10-31
- Completion
- 2012-12-31
Countries
- Italy
Study Locations
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