Clinical Trial: Evaluating Alternative Medical Therapies in Primary Hyperparathyroidism

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Evaluating Alternative Medical Therapies in Primary Hyperparathyroidism

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.

Detailed Summary:

To conduct a double-blinded, placebo-controlled, randomized intervention study to investigate whether mineralocorticoid receptor (MR) antagonism, alone or in combination with cinacalcet, is an effective therapy for primary hyperparathyroidism (P-HPTH).

Hypothesis: MR antagonism, as a monotherapy or in combination with a calcimimetic, is a mechanism to lower parathyroid hormone (PTH) in primary hyperparathyroidism (P-HPTH).

Study Design: Sixty subjects with P-HPTH will be enrolled to randomly receive eplerenone (a potassium-sparing diuretic that directly blocks the MR), amiloride (a potassium-sparing diuretic that does not directly block the MR), or placebo for 4 weeks. Thereafter, all subjects will receive cinacalcet therapy (a calcimimetic that lowers PTH) in addition to their randomized intervention for an additional 2 weeks.

Anticipated Results: In this proof-of-concept study, eplerenone therapy will lower PTH, serum calcium, and markers of bone resorption in P-HPTH, when compared to placebo. The PTH response to amiloride will resemble that of placebo, suggesting that the eplerenone mediated reductions in PTH are specific to interactions with the MR. Combination therapy with eplerenone + cinacalcet will result in additive or synergistic reductions in PTH, when compared to placebo + cinacalcet or placebo + amiloride.

Implications: MR antagonism (alone or in combination with cinacalcet) may be a mechanism to lower PTH and calcium in P-HPTH, thereby identifying a new potential option in the limited medical therapies for P-HPTH.


Sponsor: Brigham and Women's Hospital

Current Primary Outcome: Change in parathyroid hormone levels [ Time Frame: 4 weeks ]

Change in circulating PTH levels before and after intervention when compared to placebo


Original Primary Outcome: Same as current

Current Secondary Outcome: Change in calcium levels [ Time Frame: 4 weeks ]

Change in serum calcium levels before and after intervention when compared to placebo


Original Secondary Outcome:

  • Change in calcium levels [ Time Frame: 4 weeks ]
    Change in serum calcium levels before and after intervention when compared to placebo
  • Change in markers of bone resorption [ Time Frame: 4 weeks ]
    Change in circulating markers of bone resorption (C-telopeptide) levels before and after intervention when compared to placebo


Information By: Brigham and Women's Hospital

Dates:
Date Received: August 14, 2015
Date Started: January 2016
Date Completion: December 2020
Last Updated: December 22, 2016
Last Verified: December 2016