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Efficacy of Cinacalcet in the Control of Primary Hyperparathyroidism (CA-PHP)

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ClinicalTrials.gov Identifier: NCT02417389
Recruitment Status : Completed
First Posted : April 15, 2015
Last Update Posted : April 15, 2015
Sponsor:
Information provided by (Responsible Party):
Maria Luisa Bianchi, Istituto Auxologico Italiano

Brief Summary:
To assess the efficacy and safety of treatment with cinacalcet and with cinacalcet plus alendronate in controlling bone loss induced by primary hyperparathyroidism.

Condition or disease Intervention/treatment Phase
Hyperparathyroidism, Primary Osteoporosis Drug: cinacalcet Drug: Alendronate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of a Calcimimetic (Cinacalcet) in the Long Term Control of Patients With Primary Hyperparathyroidism
Study Start Date : May 2008
Actual Primary Completion Date : October 2011
Actual Study Completion Date : December 2012


Arm Intervention/treatment
Experimental: cinacalcet
Phase 1 (12 months): all patients treated with cinacalcet alone; Phase 2 (12 months): all patients treated with cinacalcet plus alendronate
Drug: cinacalcet
During Phase 1 (months 1-12): oral administration; 30 mg twice/day (dose to be increased if needed).
Other Name: Mimpara

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).
Other Names:
  • Alendronic acid
  • Fosamax




Primary Outcome Measures :
  1. percentage of patients reaching normal serum levels of calcium and maintaining these levels at end of Phase 1 and Phase 2. [ Time Frame: 24 months ]
    calcemia measurement

  2. percentage of patients obtaining a reduction of serum levels of calcium of at least 0.5 mg/dl below their baseline values and maintaining such reduction at end of Phase 1 and Phase 2. [ Time Frame: 24 months ]
    calcemia measurement

  3. percentage of patients obtaining an increase of spine or femoral BMD of 2.5% or more with respect to their baseline values at end of Phase 1 and Phase 2. [ Time Frame: 24 months ]
    DXA BMD measurement at spine and hip


Secondary Outcome Measures :
  1. reduction of serum BSAP with respect to baseline value [ Time Frame: 12 months and 24 months ]
    BSAP measurement

  2. reduction of serum CTx with respect to baseline value [ Time Frame: 12 months and 24 months ]
    CTx measurement

  3. reduction of urinary NTx with respect to baseline value [ Time Frame: 12 months and 24 months ]
    NTx measurement

  4. change of spine and femoral BMD with respect to baseline values [ Time Frame: 12 months and 24 months ]
    DXA BMD measurement at spine and hip



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. patients affected by moderate to severe PHP without instrumental (echography, neck CT, scintigraphy with Sestamibi) evidence of parathyroid adenoma or hyperplasia; OR patients affected by PHP and previously surgically treated, but recidivating without instrumental evidence of parathyroid adenoma or hyperplasia; OR patients affected by PHP and judged inoperable because of other pathologies
  2. patients with serum total calcium between 10.5 and 12.5 mg/dl (inclusive)
  3. males: age ≥50 years; females: age ≥50 years, in menopause for at least 2 years;
  4. patients with reduction of bone density (T-score ≤ -2 at spine OR hip, by DXA scan)
  5. informed consent signed at enrolment

Exclusion Criteria:

  1. lack of informed consent;
  2. presence of other diseases known to cause hypercalcemia (e.g. familial benign hypercalcemia);
  3. previous or ongoing therapies interfering with calcium and bone metabolism;
  4. impaired liver and/or renal function (i.e. serum aspartate aminotransferase, alanine aminotransferase and total bilirubin twice the upper limit of normal or more; creatinine clearance lower than 60 ml/min);
  5. history of seizures, malignancy, myocardial infarction;
  6. previous exposure to cinacalcet.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02417389


Locations
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Italy
Istituto Auxologico Italiano IRCCS
Milano, Italy, 20145
Sponsors and Collaborators
Istituto Auxologico Italiano
Investigators
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Principal Investigator: Maria Luisa BIANCHI, M.D. Istituto Auxologico Italiano IRCCS
Publications:

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Responsible Party: Maria Luisa Bianchi, M.D., Istituto Auxologico Italiano
ClinicalTrials.gov Identifier: NCT02417389    
Other Study ID Numbers: 02A605_2006
First Posted: April 15, 2015    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 2015
Keywords provided by Maria Luisa Bianchi, Istituto Auxologico Italiano:
primary hyperparathyroidism
hypercalcemia
osteoporosis
bone turnover
bone mineral density
fractures
Additional relevant MeSH terms:
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Osteoporosis
Hyperparathyroidism
Hyperparathyroidism, Primary
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Parathyroid Diseases
Endocrine System Diseases
Alendronate
Cinacalcet
Bone Density Conservation Agents
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists