NCT02417389

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

3.4 years

First QC Date

April 8, 2015

Last Update Submit

April 11, 2015

Conditions

Hyperparathyroidism, PrimaryOsteoporosis

Keywords

primary hyperparathyroidismhypercalcemiaosteoporosisbone turnoverbone mineral densityfractures

Outcome Measures

Primary Outcomes (3)

  • percentage of patients reaching normal serum levels of calcium and maintaining these levels at end of Phase 1 and Phase 2.

    calcemia measurement

    24 months

  • 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.

    calcemia measurement

    24 months

  • 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.

    DXA BMD measurement at spine and hip

    24 months

Secondary Outcomes (4)

  • reduction of serum BSAP with respect to baseline value

    12 months and 24 months

  • reduction of serum CTx with respect to baseline value

    12 months and 24 months

  • reduction of urinary NTx with respect to baseline value

    12 months and 24 months

  • change of spine and femoral BMD with respect to baseline values

    12 months and 24 months

Study Arms (1)

cinacalcet

EXPERIMENTAL

Phase 1 (12 months): all patients treated with cinacalcet alone; Phase 2 (12 months): all patients treated with cinacalcet plus alendronate

Drug: cinacalcetDrug: Alendronate

Interventions

cinacalcetDRUG

During Phase 1 (months 1-12): oral administration; 30 mg twice/day (dose to be increased if needed).

Also known as: Mimpara
cinacalcet
AlendronateDRUG

During Phase 2 (months 13-24): oral administration; 70 mg once/week (in addition to cinacalcet 30 mg twice/day as during Phase 1).

Also known as: Alendronic acid, Fosamax
cinacalcet

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • patients with serum total calcium between 10.5 and 12.5 mg/dl (inclusive)
  • males: age ≥50 years; females: age ≥50 years, in menopause for at least 2 years;
  • patients with reduction of bone density (T-score ≤ -2 at spine OR hip, by DXA scan)
  • informed consent signed at enrolment

You may not qualify if:

  • lack of informed consent;
  • presence of other diseases known to cause hypercalcemia (e.g. familial benign hypercalcemia);
  • previous or ongoing therapies interfering with calcium and bone metabolism;
  • 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);
  • history of seizures, malignancy, myocardial infarction;
  • previous exposure to cinacalcet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano IRCCS

Milan, 20145, Italy

Location

Related Publications (12)

  • Dong BJ. Cinacalcet: An oral calcimimetic agent for the management of hyperparathyroidism. Clin Ther. 2005 Nov;27(11):1725-51. doi: 10.1016/j.clinthera.2005.11.015.

    PMID: 16368445BACKGROUND

  • Block GA, Martin KJ, de Francisco AL, Turner SA, Avram MM, Suranyi MG, Hercz G, Cunningham J, Abu-Alfa AK, Messa P, Coyne DW, Locatelli F, Cohen RM, Evenepoel P, Moe SM, Fournier A, Braun J, McCary LC, Zani VJ, Olson KA, Drueke TB, Goodman WG. Cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis. N Engl J Med. 2004 Apr 8;350(15):1516-25. doi: 10.1056/NEJMoa031633.

    PMID: 15071126BACKGROUND

  • Lindberg JS, Culleton B, Wong G, Borah MF, Clark RV, Shapiro WB, Roger SD, Husserl FE, Klassen PS, Guo MD, Albizem MB, Coburn JW. Cinacalcet HCl, an oral calcimimetic agent for the treatment of secondary hyperparathyroidism in hemodialysis and peritoneal dialysis: a randomized, double-blind, multicenter study. J Am Soc Nephrol. 2005 Mar;16(3):800-7. doi: 10.1681/ASN.2004060512. Epub 2005 Feb 2.

    PMID: 15689407BACKGROUND

  • Moe SM, Cunningham J, Bommer J, Adler S, Rosansky SJ, Urena-Torres P, Albizem MB, Guo MD, Zani VJ, Goodman WG, Sprague SM. Long-term treatment of secondary hyperparathyroidism with the calcimimetic cinacalcet HCl. Nephrol Dial Transplant. 2005 Oct;20(10):2186-93. doi: 10.1093/ndt/gfh966. Epub 2005 Jul 19.

    PMID: 16030053BACKGROUND

  • Cunningham J, Danese M, Olson K, Klassen P, Chertow GM. Effects of the calcimimetic cinacalcet HCl on cardiovascular disease, fracture, and health-related quality of life in secondary hyperparathyroidism. Kidney Int. 2005 Oct;68(4):1793-800. doi: 10.1111/j.1523-1755.2005.00596.x.

    PMID: 16164656BACKGROUND

  • Barman Balfour JA, Scott LJ. Cinacalcet hydrochloride. Drugs. 2005;65(2):271-81. doi: 10.2165/00003495-200565020-00007.

    PMID: 15631545BACKGROUND

  • Shoback DM, Bilezikian JP, Turner SA, McCary LC, Guo MD, Peacock M. The calcimimetic cinacalcet normalizes serum calcium in subjects with primary hyperparathyroidism. J Clin Endocrinol Metab. 2003 Dec;88(12):5644-9. doi: 10.1210/jc.2002-021597.

    PMID: 14671147BACKGROUND

  • Peacock M, Bilezikian JP, Klassen PS, Guo MD, Turner SA, Shoback D. Cinacalcet hydrochloride maintains long-term normocalcemia in patients with primary hyperparathyroidism. J Clin Endocrinol Metab. 2005 Jan;90(1):135-41. doi: 10.1210/jc.2004-0842. Epub 2004 Nov 2.

    PMID: 15522938BACKGROUND

  • Silverberg SJ, Bilezikian JP. The diagnosis and management of asymptomatic primary hyperparathyroidism. Nat Clin Pract Endocrinol Metab. 2006 Sep;2(9):494-503. doi: 10.1038/ncpendmet0265.

    PMID: 16957763BACKGROUND

  • Bilezikian JP, Brandi ML, Rubin M, Silverberg SJ. Primary hyperparathyroidism: new concepts in clinical, densitometric and biochemical features. J Intern Med. 2005 Jan;257(1):6-17. doi: 10.1111/j.1365-2796.2004.01422.x.

    PMID: 15606372BACKGROUND

  • Bilezikian JP, Potts JT Jr, Fuleihan Gel-H, Kleerekoper M, Neer R, Peacock M, Rastad J, Silverberg SJ, Udelsman R, Wells SA. Summary statement from a workshop on asymptomatic primary hyperparathyroidism: a perspective for the 21st century. J Clin Endocrinol Metab. 2002 Dec;87(12):5353-61. doi: 10.1210/jc.2002-021370. No abstract available.

    PMID: 12466320BACKGROUND

  • Jorde R, Bonaa KH, Sundsfjord J. Primary hyperparathyroidism detected in a health screening. The Tromso study. J Clin Epidemiol. 2000 Nov;53(11):1164-9. doi: 10.1016/s0895-4356(00)00239-0.

    PMID: 11106891BACKGROUND

MeSH Terms

Conditions

Hyperparathyroidism, PrimaryOsteoporosisHypercalcemiaFractures, Bone

Interventions

CinacalcetAlendronate

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesCalcium Metabolism DisordersWater-Electrolyte ImbalanceWounds and Injuries

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsDiphosphonatesOrganophosphonatesOrganophosphorus Compounds

Study Officials

  • Maria Luisa BIANCHI, M.D.

    Istituto Auxologico Italiano IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

April 8, 2015

First Posted

April 15, 2015

Study Start

May 1, 2008

Primary Completion

October 1, 2011

Study Completion

December 1, 2012

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

IT(1)