A randomized Crossover TrIal to Compare recombinant human rhPTH(1-34) to the ASsociation alfacalcidol/hydrochlorothiazide in the treatment of Autosomal Dominant Hypocalcemia

A randomized Crossover TrIal to Compare recombinant human rhPTH(1-34) to the ASsociation alfacalcidol/hydrochlorothiazide in the treatment of Autosomal Dominant Hypocalcemia - ACTICAS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000500-29-FR

Enrollment

Registered

2016-04-26

Start date

2016-06-03

Completion date

Unknown

Last updated

2020-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autosomal dominant hypocalcemia (ADH) MedDRA version: 19.0 Level: PT Classification code 10021041 Term: Hypoparathyroidism System Organ Class: 10014698 - Endocrine disorders

Interventions

Trade Name: FORSTEO-R Product Name: FORSTEO-R Pharmaceutical Form: Solution for injection INN or Proposed INN: Tériparatide CAS Number: 52232-67-4 Other descriptive name: FORSTEO-R Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged from 18 to 80 years, of both sexes - With genetically proven ADH type 1 (CASR activating mutation) - Affiliated to a French health insurance system, and who have consented to the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 13

Exclusion criteria

Exclusion criteria: - Women of childbearing age without contraception - For men aged from 18 to 20 years, presence of cartilage of growth on X-ray of left knee - Estimated GFR (MDRD) 2N) - Intolerance to amiloride or other component of the drug - Association to other potassium sparing diuretics

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the non-inferiority on serum calcium of 40 µg rhPTH(1-34) to the combination of 25 mg hydrochlorothiazide/0.5 µg alfacalcidol;Secondary Objective: - To assess the impact of treatments on urinary calcium (plasma calcium concentrations as well as glomerular filtration rate are needed to interpret urinary excretion of calcium) - To assess the safety of the two therapeutic approaches including the biological tolerance to treatments and hypercalciuria - To assess the risk of stone formation - To assess the impact on clinical symptoms of hypoparathyroidism - To assess specifically the impact of the treatment on the quality of life and cognitive functions;Primary end point(s): Primary endpoint : ionized serum calcium level measured at two months of treatment by rhPTH(1-34) versus ionized serum calcium level measured at two months of treatment by an association alfacalcidol/hydrochlorothiazide Secondary endpoints : - Ambulatory measurement of serum calcium level at days 7 an 28 of treatment by rhPTH(1-34) and association alfacalcidol/hydrochlorothiazide and at day 14 of non-treatment periods (run in, wash out, run out). - 24h-urinary calcium excretion (expressed as mmol/24h and mmol/mmol creatinine) at every visit - Plasma calcium x phosphate product - Tolerance of thiazides and amiloride : blood pressure, serum sodium, potassium and creatinine concentration (and estimated GFR by MDRD formulae); plasma renin and aldosterone concentrations; 24h-urinary sodium, potassium and aldosterone excretions - Plasma 25 OH vitamin D, 1,25(OH)2 vitamin D concentrations - Serum magnesium concentration and 24h-urinary magnesium excretion - For assessment of stone formation risk : calcium/citrate and calcium/creatinine ratios measured on spot urines, and cristaluria : number of crystals, type of crystals. - For evaluation of the impact of rhPTH(1-34) on bone: alkaline phosphatase measured at every visit - Tolerance criteria : number of episodes of cramps, paresth	—

Measure

Time frame

Main Objective: To assess the non-inferiority on serum calcium of 40 µg rhPTH(1-34) to the combination of 25 mg hydrochlorothiazide/0.5 µg alfacalcidol;Secondary Objective: - To assess the impact of treatments on urinary calcium (plasma calcium concentrations as well as glomerular filtration rate are needed to interpret urinary excretion of calcium) - To assess the safety of the two therapeutic approaches including the biological tolerance to treatments and hypercalciuria - To assess the risk of stone formation - To assess the impact on clinical symptoms of hypoparathyroidism - To assess specifically the impact of the treatment on the quality of life and cognitive functions;Primary end point(s): Primary endpoint : ionized serum calcium level measured at two months of treatment by rhPTH(1-34) versus ionized serum calcium level measured at two months of treatment by an association alfacalcidol/hydrochlorothiazide Secondary endpoints : - Ambulatory measurement of serum calcium level at days 7 an 28 of treatment by rhPTH(1-34) and association alfacalcidol/hydrochlorothiazide and at day 14 of non-treatment periods (run in, wash out, run out). - 24h-urinary calcium excretion (expressed as mmol/24h and mmol/mmol creatinine) at every visit - Plasma calcium x phosphate product - Tolerance of thiazides and amiloride : blood pressure, serum sodium, potassium and creatinine concentration (and estimated GFR by MDRD formulae); plasma renin and aldosterone concentrations; 24h-urinary sodium, potassium and aldosterone excretions - Plasma 25 OH vitamin D, 1,25(OH)2 vitamin D concentrations - Serum magnesium concentration and 24h-urinary magnesium excretion - For assessment of stone formation risk : calcium/citrate and calcium/creatinine ratios measured on spot urines, and cristaluria : number of crystals, type of crystals. - For evaluation of the impact of rhPTH(1-34) on bone: alkaline phosphatase measured at every visit - Tolerance criteria : number of episodes of cramps, paresth

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Secondary

Measure	Time frame
Secondary end point(s): - Ambulatory measurement of serum calcium level at days 7 an 28 of treatment by rhPTH(1-34) and association alfacalcidol/hydrochlorothiazide and at day 14 of non-treatment periods (run in, wash out, run out). - 24h-urinary calcium excretion (expressed as mmol/24h and mmol/mmol creatinine) at every visit - Plasma calcium x phosphate product - Tolerance of thiazides and amiloride : blood pressure, serum sodium, potassium and creatinine concentration (and estimated GFR by MDRD formulae); plasma renin and aldosterone concentrations; 24h-urinary sodium, potassium and aldosterone excretions - Plasma 25 OH vitamin D, 1,25(OH)2 vitamin D concentrations - Serum magnesium concentration and 24h-urinary magnesium excretion - For assessment of stone formation risk : calcium/citrate and calcium/creatinine ratios measured on spot urines, and cristaluria : number of crystals, type of crystals. - For evaluation of the impact of rhPTH(1-34) on bone: alkaline phosphatase measured at every visit - Tolerance criteria : number of episodes of cramps, paresthesia, tetany or seizures, - Other adverse events - Quality of Life (self-administered questionnaire SF36);Timepoint(s) of evaluation of this end point: 8 months	—

Measure

Time frame

Secondary end point(s): - Ambulatory measurement of serum calcium level at days 7 an 28 of treatment by rhPTH(1-34) and association alfacalcidol/hydrochlorothiazide and at day 14 of non-treatment periods (run in, wash out, run out). - 24h-urinary calcium excretion (expressed as mmol/24h and mmol/mmol creatinine) at every visit - Plasma calcium x phosphate product - Tolerance of thiazides and amiloride : blood pressure, serum sodium, potassium and creatinine concentration (and estimated GFR by MDRD formulae); plasma renin and aldosterone concentrations; 24h-urinary sodium, potassium and aldosterone excretions - Plasma 25 OH vitamin D, 1,25(OH)2 vitamin D concentrations - Serum magnesium concentration and 24h-urinary magnesium excretion - For assessment of stone formation risk : calcium/citrate and calcium/creatinine ratios measured on spot urines, and cristaluria : number of crystals, type of crystals. - For evaluation of the impact of rhPTH(1-34) on bone: alkaline phosphatase measured at every visit - Tolerance criteria : number of episodes of cramps, paresthesia, tetany or seizures, - Other adverse events - Quality of Life (self-administered questionnaire SF36);Timepoint(s) of evaluation of this end point: 8 months

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Countries

France

Contacts

Public ContactDRCD Hôpital St Louis

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

karine.goude@aphp.fr

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026