A study in patients eligible for Calcium and Vitamin D supplementation to evaluate subject preference and acceptability of a new formulation of Calcichew D3

Phase 1

• Conditions: Prevention and treatment of vitamin D and calcium deficiency and adjunct to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency; MedDRA version: 18.0 Level: LLT Classification code 10031289 Term: Osteoporosis, unspecified System Organ Class: 100000004859; MedDRA version: 18.0 Level: SOC Classification code 10027433 Term: Metabolism and nutrition disorders System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2014-005619-18-GB
• Lead Sponsor: Takeda Development Centre Europe Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-12
• Study Completion: 2015-08-27
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 276

Inclusion Criteria

Subject eligibility is determined according to the following criteria prior to entry into the study:
1. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
2. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
3. The subject is eligible for or currently receiving treatment with calcium and vitamin D supplement as determined by the treating clinician in accordance with local treatment guidelines.
4. Eligible subjects will either be:
a. Subjects aged 65 years or older requiring calcium and vitamin D supplementation for the prevention or treatment of deficiencies, or
b. Subjects aged 18 years or older that require calcium and vitamin D as an adjunct to specific osteoporosis treatment in subjects at risk of calcium and vitamin D deficiencies.
5. The subject is male or female.
6. A female subject of childbearing potential *who is sexually active with a nonsterilized* male partner agrees to use routinely adequate contraception* from signing of informed consent throughout the duration of the study and for 12 weeks after last dose of study medication. *Definitions and acceptable methods of contraception are defined in Section 9.1.10 Contraception and Pregnancy Avoidance Procedure and reporting responsibilities are defined in Section 9.1.11 Pregnancy.
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 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 221

Exclusion Criteria

Any subject who meets any of the following criteria will not qualify for entry into the study:
1. The subject has received Calcichew D3, Adcal-D3 (if the subject is in Test Group 1) or Kalcipos-D (if the subject is in Test Group 2) within the 6 months prior to the first dose of study medication.
2. The subject has received any investigational compound within 30 days prior to Screening.
3. The subject has a disease and/or condition resulting in hypercalcaemia and/or hypercalciuria and for which the study drugs are contraindicated e.g. Zollinger-Ellison syndrome, nephrolithiasis.
4. The subject has any of the contraindications listed in the corresponding Summary of Product Characteristics (SPC) of the study drug that the patient may receive depending on the Test Group: Calcichew D3 or Adcal-D3 (if the subject is in Test Group 1); Calcichew D3 or Kalcipos-D (if the subject is in Test Group 2).
5. The subject is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
6. The subject has a history of hypersensitivity or allergies to the active substances or to any of the excipients in the investigational products.
7. The subject has a history of known fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
8. If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 12 weeks after participating in this study; or intending to donate ova during such time period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified