Clinical Trial: Efficacy of Cinacalcet in the Control of Primary Hyperparathyroidism

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy of a Calcimimetic (Cinacalcet) in the Long Term Control of Patients With Primary Hyperparathyroidism

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.

Detailed Summary:

The project was conducted at the Istituto Auxologico Italiano, IRCCS, Milano (Italy).

Principal Investigator: Maria Luisa Bianchi, M.D., Nephrologist, Bone Metabolism Unit, Istituto Auxologico Italiano IRCCS, Milan, Italy

Other investigators:

Silvia Vai, M.D., endocrinologist, Bone Metabolism Unit, Istituto Auxologico Italiano IRCCS, Milan, Italy Francesca Broggi, Dr., biologist, Bone Metabolism Unit, Istituto Auxologico Italiano IRCCS, Milan, Italy Luca Persani, M.D., Endocrinologist, University of Milan & Division of Endocrine and Metabolic Diseases, Istituto Auxologico Italiano IRCCS, Milan, Italy

Introduction Cinacalcet is an orally active second-generation calcimimetic drug. Cinacalcet increases the sensitivity of calcium receptors located on the surface of parathyroid cells, thus inhibiting parathyroid hormone (PTH) secretion (which is increased in hyperparathyroidism). Cinacalcet has been approved by FDA and EMEA for the use in dialyzed patients affected by chronic renal failure with uncontrolled secondary hyperparathyroidism, on the basis of three 6-month double-blind placebo-controlled studies on more than 1,100 patients.

PTH secretion and parathyroid cell proliferation are regulated by the serum levels of ionized calcium (Ca++). The mechanism is based on the binding of the Ca++ ion to a G-protein coupled membrane receptor (GPCR), called Calcium Sensing Receptor (CaR). With low circulating levels of Ca++ or with an alteration of the calcium-receptor binding, higher amounts of PTH are secreted, hyperparathyroidism develops, and in the long term systemic alterations (bone mineral density (BMD) reduction, increased fracture risk, hypercalciuria, renal stones, hypert
Sponsor: Istituto Auxologico Italiano

Current Primary Outcome:

  • 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
  • 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
  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • reduction of serum BSAP with respect to baseline value [ Time Frame: 12 months and 24 months ]
    BSAP measurement
  • reduction of serum CTx with respect to baseline value [ Time Frame: 12 months and 24 months ]
    CTx measurement
  • reduction of urinary NTx with respect to baseline value [ Time Frame: 12 months and 24 months ]
    NTx measurement
  • 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


Original Secondary Outcome: Same as current

Information By: Istituto Auxologico Italiano

Dates:
Date Received: April 8, 2015
Date Started: May 2008
Date Completion:
Last Updated: April 11, 2015
Last Verified: April 2015