Autosomal Dominant Hypocalcemia OR Primary Hypoparathyroidism Related to Other Cause But Complicated by Hypercalciuria Under TreatmentPhase 2ACTICASNCT02824718

Recombinant Human rhPTH(1-34) VS Association Alfacalcidol/Hydrochlorothiazide in Severe Primary Hypoparathyroidism

A Phase 2 study testing Teriparatide, Thiazide and Potassium sparing diuretic in people with Autosomal Dominant Hypocalcemia OR Primary Hypoparathyroidism Related to Other Cause But Complicated by Hypercalciuria Under Treatment, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Autosomal Dominant Hypocalcemia OR Primary Hypoparathyroidism Related to Other Cause But Complicated by Hypercalciuria Under Treatment
What is being tested?: Teriparatide, Thiazide and Potassium sparing diuretic
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteFrance
Study dates: 6 Jun 2017to 28 May 2020
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients aged from 18 to 80 years, of both sexes
Patient with primary hypoparathyroidism related to a genetically proven ADH OR primary hypoparathyroidism related to other cause but complicated by hypercalciuria under treatment
Affiliated to a French health insurance system, and who have consented to the study.

Who cannot join

Pregnant and breastfeeding women;
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;
Anuria;
Kidney failure with plasmatic creatinine >125 mmol/l and urea >10 mmol/l;
Long QT interval : QTc > 450 ms (men) or 470 ms (women);

Show all 24Show fewer

Hepatic failure;
Metabolic bone diseases (Paget's disease of bone) other than primary osteoporosis or glucocorticoid-induced osteoporosis;
Association to other potassium sparing diuretics;
Hypokalemia (<3.5 mmol/l) without diuretic therapy;
Hyperkalemia (>5.5 mmol/l);
Hyponatremia (<135 mmol/l) without diuretic therapy;
Hypercalcemia (>2.6 mmol/l);
Severe hypomagnesemia (≤ 0.5 mmol/l);
Vitamin D deficiency (25OH vit D < 20 ng/mL);
Unexplained increase in alkaline phosphatase (>2N);
Intolerance to sulfamide;
Intolerance to amiloride or other component of the drug;
Hypersensitivity to any active substance or excipient of one of the experimental drugs;
Gluten intolerance;
Bone break history within the three previous months;
History of radiotherapy of the skeleton;
History of bone cancer or metastasis.
Personnal or familial (first degree relatives) of skin cancer

Trial locations and contacts

1 site in 1 country.

France1 site

AP-HP Hopital Europeen Georges Pompidou
Paris, 75015

Other trials in France

About this study

Official title: A Randomized Crossover TrIal to Compare Recombinant Human rhPTH(1-34) to the ASsociation Alfacalcidol/Hydrochlorothiazide in the Treatment of Severe Primary Hypoparathyroidism

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: rhPTH(1-34) 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.

Read the 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 0.5 µg/day alfacalcidol for 4 weeks (28±3 days, run-in). They will be instructed to maintain dietary calcium intakes (1 g/day) 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 ng/L. Magnesium supplementation (100 mg/day) 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 mg/day (ESIDREX®) + amiloride 5 mg/day (MODAMIDE®) + 0.5 µg/day alfacalcidol (ALFACALCIDOL®) or 40 µg/day rhPTH(1-34) (teriparatide or FORSTEO® 20 µg twice daily) over 7 to 8 weeks (52±3 days).

After a washout period of 28±3 days under 0.5 µg alfacalcidol /day, the patients will follow the second period of treatment. The study will end with a final period of 28±3 days under 0.5 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.

Conditions: Autosomal Dominant Hypocalcemia OR Primary Hypoparathyroidism Related to Other Cause But Complicated by Hypercalciuria Under Treatment
Being tested: Teriparatide, Thiazide, Potassium sparing diuretic, Alfacalcidol
Keywords: Hypoparathyroidism, PTH(1-34), Thiazides, Hypercalciuria, Calcium sensing receptor
Medical subject headings: Hypoparathyroidism, Hypercalciuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TeriparatideDrug
Also called FORSTEO
human recombinant parathormone
ThiazideDrug
Also called ESIDREX
Diuretic
Potassium sparing diureticDrug
Also called MODAMIDE
Diuretic
AlfacalcidolDrug
Also called UN-ALFA
Belongs to the class of vitamin D and analogues

Study groups in NCT02824718
Study group	Role	What they receive
rh PTH(1-34)	Experimental	40 µg/day rhPTH(1-34) (teriparatide or FORSTEO® 20 µg twice daily) over 7 to 8 weeks (52±3 days). Receives: Drug: Teriparatide
Thiazide + potassium sparing diuretic	Active comparator	hydrochlorothiazide 25 mg/day (ESIDREX®) + amiloride 5 mg/day (MODAMIDE®) + 0.5 µg/day alfacalcidol (ALFACALCIDOL®) over 7 to 8 weeks (52±3 days). Receives: Drug: Thiazide; Drug: Potassium sparing diuretic; Drug: Alfacalcidol

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma calcium concentration
Mean of two measures at 30-min interval of Ionized serum calcium concentration
Measured: two months of treatment

Secondary outcomes (25)

Ambulatory calcium concentration
Ambulatory measurement of serum calcium level
Measured: 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).
Calciuria
24h-urinary calcium excretion (expressed as mmol/24h and mmol/mmol creatinine)
Measured: Inclusion, weeks 4 (end of the run-in period), 7-8 (end of the first treatment period), 11-12 (end of the wash-out period), 18-20 (end of the second treatment period), 202 (end of the wash-out period)
Plasma calcium x phosphate product
Measured: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Blood pressure
Tolerance of thiazides and amiloride
Measured: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Serum sodium level
Tolerance of thiazides and amiloride
Measured: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Serum potassium level
Tolerance of thiazides and amiloride
Measured: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Estimated GFR using MDRD formula
Tolerance of thiazides and amiloride
Measured: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Serum renin level
Tolerance of thiazides and amiloride
Measured: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Serum aldosterone level
Tolerance of thiazides and amiloride
Measured: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
24h-urinary sodium excretion
Tolerance of thiazides and amiloride
Measured: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
24h-urinary potassium excretion
Tolerance of thiazides and amiloride
Measured: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
24h-urinary aldosterone excretion
Tolerance of thiazides and amiloride
Measured: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Serum 25 OH vitamin D level
Tolerance of thiazides and amiloride
Measured: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Serum 1,25(OH)2 vitamin D level
Tolerance of thiazides and amiloride
Measured: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Serum magnesium level
Tolerance of thiazides and amiloride
Measured: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
24h-urinary magnesium excretion
Tolerance of thiazides and amiloride
Measured: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Calcium/citrate ratio measured on spot urines
Assessment of stone formation risk
Measured: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Calcium/creatinine ratios measured on spot urines
Assessment of stone formation risk
Measured: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Crystalluria
Assessment of stone formation risk
Measured: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Alkaline phosphatase level
Evaluation of the impact of rhPTH(1-34) on bone
Measured: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Number of episodes of cramps
Other tolerance
Measured: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Number of episodes of paresthesia
Other tolerance
Measured: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Number of episodes of tetany
Other tolerance
Measured: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Number of episodes of seizure
Other tolerance
Measured: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
SF36 self-administered questionnaire
Evaluation of the impact on quality of life
Measured: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jun 201728 May 2020

First posted7 Jul 2016 (estimated)
Study start6 Jun 2017
Primary completion28 May 2020
Study completion28 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Autosomal Dominant Hypocalcemia OR Primary Hypoparathyroidism Related to Other Cause But Complicated by Hypercalciuria Under TreatmentStudies of the same condition, open and under way.
More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02824718
Sponsor's protocol ID: P150911
Other IDs: PHRC-15-549, 2016-000500-29, 2016
Acronym: ACTICAS
Status last verified: Jun 2021
First submitted: 1 Jul 2016
Last updated: 28 Jun 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1
Autosomal Dominant Hypocalcemia (ADH)
Active, not recruitingObservational study
ADH1 and ADH2 Disease Monitoring Study (DMS)
Autosomal Dominant Hypocalcemia
RecruitingPhase 2/3
Pharmacokinetics, Efficacy, and Safety of Encaleret in Pediatric Participants With Autosomal Dominant Hypocalcemia Type 1 (ADH1)
Autosomal Dominant Hypocalcemia Type 1 (ADH1)
RecruitingObservational study
National Registry of Rare Kidney Diseases
Adenine Phosphoribosyltransferase Deficiency, AH Amyloidosis

All Autosomal Dominant Hypocalcemia OR Primary Hypoparathyroidism Related to Other Cause But Complicated by Hypercalciuria Under Treatment trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Crossover TrIal to Compare Recombinant Human rhPTH(1-34) to the ASsociation Alfacalcidol/Hydrochlorothiazide in the Treatment of Severe Primary Hypoparathyroidism
ClinicalTrials.gov ID: NCT02824718
Acronym / sponsor ID: ACTICAS / P150911
Conditions: Autosomal Dominant Hypocalcemia OR Primary Hypoparathyroidism Related to Other Cause But Complicated by Hypercalciuria Under Treatment
Keywords: Hypoparathyroidism, PTH(1-34), Thiazides, Hypercalciuria, Calcium sensing receptor
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
Collaborators: Ministry of Health, France
Study start: 6 Jun 2017 (actual)
Primary completion: 28 May 2020 (actual)
Study completion: 28 May 2020 (actual)
First posted: 7 Jul 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The design consists in a five-periods, two-treatments, open-label, randomized, crossover study with blind end-point evaluation.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
rh PTH(1-34)	Experimental	Drug: Teriparatide40 µg/day rhPTH(1-34) (teriparatide or FORSTEO® 20 µg twice daily) over 7 to 8 weeks (52±3 days).
Thiazide + potassium sparing diuretic	Active comparator	Drug: Thiazide, Drug: Potassium sparing diuretic, Drug: Alfacalcidolhydrochlorothiazide 25 mg/day (ESIDREX®) + amiloride 5 mg/day (MODAMIDE®) + 0.5 µg/day alfacalcidol (ALFACALCIDOL®) over 7 to 8 weeks (52±3 days).

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients aged from 18 to 80 years, of both sexes
Patient with primary hypoparathyroidism related to a genetically proven ADH OR primary hypoparathyroidism related to other cause but complicated by hypercalciuria under treatment
Affiliated to a French health insurance system, and who have consented to the study.

Key exclusion criteria (24 listed)

Pregnant and breastfeeding women;
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;
Anuria;
Kidney failure with plasmatic creatinine >125 mmol/l and urea >10 mmol/l;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TeriparatideAlso: FORSTEOhuman recombinant parathormone	Drug	rh PTH(1-34)
ThiazideAlso: ESIDREXDiuretic	Drug	Thiazide + potassium sparing diuretic
Potassium sparing diureticAlso: MODAMIDEDiuretic	Drug	Thiazide + potassium sparing diuretic
AlfacalcidolAlso: UN-ALFABelongs to the class of vitamin D and analogues	Drug	Thiazide + potassium sparing diuretic

Primary outcome

Plasma calcium concentration
Time frame: two months of treatment
Mean of two measures at 30-min interval of Ionized serum calcium concentration

25 secondary outcomes

Ambulatory calcium concentration
Time frame: 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).
Calciuria
Time frame: Inclusion, weeks 4 (end of the run-in period), 7-8 (end of the first treatment period), 11-12 (end of the wash-out period), 18-20 (end of the second treatment period), 202 (end of the wash-out period)
Plasma calcium x phosphate product
Time frame: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Blood pressure
Time frame: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Serum sodium level
Time frame: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Serum potassium level
Time frame: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Estimated GFR using MDRD formula
Time frame: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Serum renin level
Time frame: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Serum aldosterone level
Time frame: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
24h-urinary sodium excretion
Time frame: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
24h-urinary potassium excretion
Time frame: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
24h-urinary aldosterone excretion
Time frame: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Serum 25 OH vitamin D level
Time frame: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Serum 1,25(OH)2 vitamin D level
Time frame: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Serum magnesium level
Time frame: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
24h-urinary magnesium excretion
Time frame: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Calcium/citrate ratio measured on spot urines
Time frame: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Calcium/creatinine ratios measured on spot urines
Time frame: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Crystalluria
Time frame: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Alkaline phosphatase level
Time frame: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Number of episodes of cramps
Time frame: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Number of episodes of paresthesia
Time frame: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Number of episodes of tetany
Time frame: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
Number of episodes of seizure
Time frame: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)
SF36 self-administered questionnaire
Time frame: Inclusion, days 28 (end of the run-in period), 80 (end of the first treatment period), 108 (end of the wash-out period), 160 (end of the second treatment period), 202 (end of the wash-out period)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anne Blanchard, MD, PhD principal investigator

Assistance Publique - Hôpitaux de Paris

Agnes Linglart, MD, PhD study director

Assistance Publique - Hôpitaux de Paris

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma calcium concentration (time frame: two months of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02824718.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2021.