A Study to Assess the Efficacy and Safety of Twice-Daily Dose Regimens of an Oral Calcimimetic Agent AMG 073 (Cinacalcet) in Primary Hyperparathyroidism (PHPT)

NCT ID: NCT00936650

Last Updated: 2013-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-11-30
• Study Completion Date: 2001-06-30

Brief Summary

This randomized, placebo-controlled study in patients with primary HPT was designed to evaluate the efficacy, safety, pharmacokinetics, and health-related quality of life (HRQOL) of AMG 073 when administered 2 times a day (BID). The study consisted of 3 phases: a 12-week dose-titration phase, a 12-week maintenance phase, and a 28-week follow-up phase.

Conditions

Hyperparathyroidism, Primary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

cinacalcet

Group Type: EXPERIMENTAL

cinacalcet

Intervention Type: DRUG

Subjects were titrated to doses of 30, 40, or 50 mg BID every 4 weeks in a 12 week titration period, depending on their serum calcium concentration. The dose was kept constant for the ensuing 40 weeks except for dose reductions for hypocalcemia.

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Subjects were titrated to doses of 30, 40, or 50 mg BID every 4 weeks in a 12 week titration period, depending on their serum calcium concentration. The dose was kept constant for the ensuing 40 weeks except for dose reductions for hypocalcemia.

Interventions

placebo

Subjects were titrated to doses of 30, 40, or 50 mg BID every 4 weeks in a 12 week titration period, depending on their serum calcium concentration. The dose was kept constant for the ensuing 40 weeks except for dose reductions for hypocalcemia.

Intervention Type: DRUG

cinacalcet

Subjects were titrated to doses of 30, 40, or 50 mg BID every 4 weeks in a 12 week titration period, depending on their serum calcium concentration. The dose was kept constant for the ensuing 40 weeks except for dose reductions for hypocalcemia.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Men or women ≥ 18 years of age at screening
• Using, in the opinion of the principal investigator, effective contraceptive measures
• Plasma iPTH concentration > 45 pg/mL on at least 2 occasions at least 7 days apart during the 12 months preceding day 0 (at least 1 of these determinations should have been made during screening by the central lab) and serum calcium concentration > 10.3 mg/dL and ≤ 12.5 mg/dL on at least 2 occasions at least 7 days apart
• Acceptable renal function, with an estimated creatinine clearance > 50 mL/min as determined by the Cockroft and Gault equation
• Acceptable hepatic function, defined as serum aspartate aminotransferase, alanine aminotansferase, and total bilirubin ≤ 2 times the upper limit of normal according to the range provided by the central laboratory

Exclusion Criteria

• Chest x-ray within the previous 12 months without evidence of an active infectious, inflammatory, or malignant process
• Subject or legally acceptable representative gave informed consent for participation in the study

• Unstable medical condition, defined as having been hospitalized within 30 days before day 0
• Pregnant or nursing
• Body habitus that precluded accurate DXA measurements
• Therapy within 21 days before day 0 with systemic glucocorticoids, lithium, tricyclic antidepressants with the exception of amitriptyline and nortryptiline, thioridazine, haloperidol, flecainide or other drugs with a narrow therapeutic index that are primarily metabolized by hepatic cytochrome P450 (CYP) 2D6, drugs that affect renal tubular calcium handling (eg, thiazide or loop diuretics), or calcitonin
• Received, within 90 days before day 0, therapy with bisphosphonates, with fluoride, or changes in thyroid replacement therapy
• Dose changes in selective estrogen receptor modulators (SERMs), or significant changes in doses of estrogen within 90 days before day 0. If a subject had discontinued estrogen or SERM therapy, they must have been off treatment for at least 90 days before day 0
• Alcohol abuse, or use of illicit drugs, within 12 months before day 0
• Myocardial infarction (MI) within 6 months before day 0
• Ventricular rhythm disturbance requiring current treatment
• Seizures within 12 months before day 0
• History (within 5 years) of malignancy of any type, other than nonmelanomatous skin cancers or in situ cervical cancer
• Within the past 5 years, evidence of treatment for and/or active sarcoidosis, tuberculosis, or other diseases known to cause hypercalcemia
• History of familial hypocalciuric hypercalcemia (FHH)
• Uncontrolled diabetes, as defined by hemoglobin A1c (HbA1c) ≥ 8.0
• Gastrointestinal disorder that might have been associated with impaired absorption of orally dministered medications
• Inability to swallow tablets
• Known sensitivity to any of the products to be administered during the study
• Psychiatric disorder that would have interfered with understanding and giving informed consent or compliance with protocol requirements
• Other condition that might have reduced the chance of obtaining data (eg, known poor compliance) required by the protocol or that might have compromised the ability to give truly informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Amgen Inc.

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

References

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.

Reference Type: RESULT

PMID: 15522938 (View on PubMed)

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

990120

Identifier Type: -

Identifier Source: org_study_id