Ignite Creation Date:
2024-05-06 @ 8:49 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02824718
Status:
COMPLETED
Last Update Posted:
2021-06-28
First Post:
2016-07-01
Brief Title:
Recombinant Human rhPTH1-34 VS Association AlfacalcidolHydrochlorothiazide in Severe Primary Hypoparathyroidism
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
A Randomized Crossover TrIal to Compare Recombinant Human rhPTH1-34 to the ASsociation AlfacalcidolHydrochlorothiazide in the Treatment of Severe Primary Hypoparathyroidism
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACTICAS
Brief Summary:
Hypoparathyroidism is a rare condition in which the parathyroid glands fail to produce sufficient amount of parathyroid hormone or the parathyroid hormone produced lacks biologic activity The most common cause of hypoparathyroidism is damage to or removal of the parathyroid glands due to neck surgery for another condition Occurrence of hypercalciuria under treatment is a frequent concern in primary hypoparathyroidism limiting correction of hypocalcemia
Hypoparathyroidism can also be caused by an autoimmune process In rare cases hypoparathyroidism may occur as a genetic disorder inherited as an autosomal recessive autosomal dominant or X-linked recessive trait The autosomal dominant hypocalcemia ADH is mainly caused by heterozygous activating mutations in the CASR gene encoding CaSR As other severe presentation of primary hypothyroidism ADH is characterized by the increased risk to develop hypercalciuria and nephrolithiasis The purpose of the study is to compare two therapeutic approaches in severe hypoparathyroidism in order to limit the risk of nephrocalcinosis and renal failure when attempting to correct hypocalcemia rhPTH1-34 vs association of active vitamin D and hydrochlorothiazide The European Society of Endocrinology Clinical has indeed recently published guidelines for the treatment of chronic hypoparathyroidism in adults These guidelines suggest considering treatment with a thiazide diuretic In a patient with hypercalciuria and replacement therapy with PTH in patients who do not stably and safely maintain their serum and urinary calcium in the target range
Hypoparathyroidism can also be caused by an autoimmune process In rare cases hypoparathyroidism may occur as a genetic disorder inherited as an autosomal recessive autosomal dominant or X-linked recessive trait The autosomal dominant hypocalcemia ADH is mainly caused by heterozygous activating mutations in the CASR gene encoding CaSR As other severe presentation of primary hypothyroidism ADH is characterized by the increased risk to develop hypercalciuria and nephrolithiasis The purpose of the study is to compare two therapeutic approaches in severe hypoparathyroidism in order to limit the risk of nephrocalcinosis and renal failure when attempting to correct hypocalcemia rhPTH1-34 vs association of active vitamin D and hydrochlorothiazide The European Society of Endocrinology Clinical has indeed recently published guidelines for the treatment of chronic hypoparathyroidism in adults These guidelines suggest considering treatment with a thiazide diuretic In a patient with hypercalciuria and replacement therapy with PTH in patients who do not stably and safely maintain their serum and urinary calcium in the target range
Detailed Description:
The design consists in a five-periods two-treatments open-label randomized crossover study with blind end-point evaluation
Patients will come for an inclusion visit and will receive treatment with 05 µgday alfacalcidol for 4 weeks 283 days run-in They will be instructed to maintain dietary calcium intakes 1 gday for the duration of the study and will be supplemented throughout the study with native vitamin D in order to maintain the concentration of 25OH vitamin D 40 ngL Magnesium supplementation 100 mgday will be maintained throughout the study
At inclusion patients will be randomly assigned to receive at the end of run-in period in cross-over either an association hydrochlorothiazide 25 mgday ESIDREX amiloride 5 mgday MODAMIDE 05 µgday alfacalcidol ALFACALCIDOL or 40 µgday rhPTH1-34 teriparatide or FORSTEO 20 µg twice daily over 7 to 8 weeks 523 days
After a washout period of 283 days under 05 µg alfacalcidol day the patients will follow the second period of treatment The study will end with a final period of 283 days under 05 µg alfacalcidol day Patients will ambulatory monitor serum calcium sodium potassium and creatinine levels at days 15 of run in and run out periods and at day 7 and day 28 of each treatment period
Patients will come for an inclusion visit and will receive treatment with 05 µgday alfacalcidol for 4 weeks 283 days run-in They will be instructed to maintain dietary calcium intakes 1 gday for the duration of the study and will be supplemented throughout the study with native vitamin D in order to maintain the concentration of 25OH vitamin D 40 ngL Magnesium supplementation 100 mgday will be maintained throughout the study
At inclusion patients will be randomly assigned to receive at the end of run-in period in cross-over either an association hydrochlorothiazide 25 mgday ESIDREX amiloride 5 mgday MODAMIDE 05 µgday alfacalcidol ALFACALCIDOL or 40 µgday rhPTH1-34 teriparatide or FORSTEO 20 µg twice daily over 7 to 8 weeks 523 days
After a washout period of 283 days under 05 µg alfacalcidol day the patients will follow the second period of treatment The study will end with a final period of 283 days under 05 µg alfacalcidol day Patients will ambulatory monitor serum calcium sodium potassium and creatinine levels at days 15 of run in and run out periods and at day 7 and day 28 of each treatment period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PHRC-15-549 | OTHER_GRANT | None | None |
| 2016-000500-29 | EUDRACT_NUMBER | Ministry of health France | None |