Phase 3
Completed N=41
Evaluating Alternative Medical Therapies in Primary Hyperparathyroidism
Primary Hyperparathyroidism
Source: ClinicalTrials.gov NCT02525796 ↗
Enrolled (actual)
41
Serious AEs
0.0%
Results posted
May 2023
Primary outcomePrimary: Change in Parathyroid Hormone Levels — 4.0; -3.7; 0.8 pg/mL — p=0.84
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Parathyroid Hormone Levels |
4.0; -3.7; 0.8 | 0.84 |
| SECONDARY Change in Calcium Levels |
0.1; 0.0; 0.1 | 0.82 |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- estimated glomerular filtration rate 5.0 mmol/L
- age 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.
Data sourced from ClinicalTrials.gov (NCT02525796). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.