Evaluating Alternative Medical Therapies in Primary Hyperparathyroidism

NCT02525796 | Completed Phase 2 Results

• 1 other identifier: 107407
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate whether blocking the mineralocorticoid receptor, alone, or in combination with the calcimimetic cinacalcet, can lower parathyroid hormone and calcium levels in primary hyperparathyroidism.

Conditions

Primary Hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

• Change in Parathyroid Hormone Levels

  Change in circulating PTH levels before and after 4 weeks of double-blinded intervention when compared to placebo

  Change in circulating PTH levels before and after 4 weeks of double-blinded monotherapy intervention when compared to placebo (PTH at 4 weeks minus PTH at baseline)

Secondary Outcomes (1)

• Change in Calcium Levels

  Change in serum calcium levels before and after 4 weeks of double-blinded monotherapy intervention when compared to placebo (calcium at 4 weeks minus calcium at baseline)

Study Arms (3)

Placebo + Cinacalcet

PLACEBO COMPARATOR

Patients with primary hyperparathyroidism will receive placebo for 4 weeks followed by the addition of cinacalcet for 2 weeks

Drug: Placebo; Drug: Cinacalcet

Amiloride + Cinacalcet

ACTIVE COMPARATOR

Patients with primary hyperparathyroidism will receive amiloride for 4 weeks followed by the addition of cinacalcet for 2 weeks

Drug: amiloride; Drug: Cinacalcet

Eplerenone + Cinacalcet

EXPERIMENTAL

Patients with primary hyperparathyroidism will receive eplerenone for 4 weeks followed by the addition of cinacalcet for 2 weeks

Drug: eplerenone; Drug: Cinacalcet

Interventions

eplerenone DRUG

eplerenone, titrated up to a maximum of 50mg BID

Eplerenone + Cinacalcet

amiloride DRUG

amiloride, titrated up to a maximum of 10mg BID

Amiloride + Cinacalcet

Placebo DRUG

Placebo + Cinacalcet

Cinacalcet DRUG

Cinacalcet, as add-on therapy in addition to eplerenone/amiloride/placebo, titrated up to a maximum of 30mg BID

Amiloride + Cinacalcet; Eplerenone + Cinacalcet; Placebo + Cinacalcet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• physician diagnosis of active P-HPTH (Serum calcium \> upper limit of reference range and serum PTH \> ULRR; or Serum Calcium \> ULRR AND serum PTH \> 30 pg/mL; or Serum Calcium within 0.2 mg/dL of the ULRR and PTH\>ULRR).
• negative pregnancy test in women aged 18-45

You may not qualify if:

• estimated glomerular filtration rate \< 60mL/min/1,73m2
• serum potassium \> 5.0 mmol/L
• age \<18 or \>80 years
• diabetes that is not well controlled (HbA1c\>8%)\\
• liver failure
• heart failure
• history of myocardial infarction or stroke
• active use of lithium
• active chronic inflammatory conditions (such as inflammatory bowel disease, rheumatoid arthritis, sarcoidosis)
• initiation within 3 months of bisphosphonates or cinacalcet
• need for imminent parathyroidectomy (within the next 6-8 weeks) as determined by their endocrinologist or surgeon
• absolute serum calcium \>13.0 mg/dL
• positive pregnancy test on any of the study visits for women ages 18-45.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Interventions

Eplerenone; Amiloride; Cinacalcet

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Anand Vaidya
• Organization: Brigham and Women's Hospital

anandvaidya@bwh.harvard.edu

16177325666

Study Officials

• Anand Vaidya, MD MMSc

  Brigham and Women's Hospital, Harvard Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Harvard Medical School

Model Details: 3-parallel-armed double-blinded randomized controlled trial wherein monotherapy of eplerenone or amiloride or placebo administered for 4 weeks. After weeks, an open-label extension addition of cinacalcet to all 3 arms conducted for 2 weeks.

Study Record Dates

• First Submitted: August 14, 2015
• First Posted: August 17, 2015
• Study Start: January 1, 2016
• Primary Completion: October 1, 2021
• Study Completion: October 2, 2021
• Last Updated: May 3, 2023
• Results First Posted: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)