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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005619-18 | EudraCT Number | ||
| U1111-1166-8818 | Registry Identifier | WHO | |
| 15/NW/0275 | Registry Identifier | NRES |
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The purpose of this study is to compare the preference of Calcichew D3 500/400 (containing 500 mg calcium and 400 IU of vitamin D) with Adcal-D3 600/400 (containing 600 mg of calcium and 400 IU of vitamin D) in Test Group 1, and to compare Calcichew D3 500/800 (containing 500 mg calcium and 800 IU vitamin D) with Kalcipos-D 500/800 (containing 500 mg of calcium and 800 IU of vitamin D) in Test Group 2.
The drug being tested in this study is called Calcichew D3 new formulations: Calcichew D3 500/400 and Calcichew D3 500/800. Calcichew D3 500/400 and Calcichew D3 500/800 are being tested to treat or prevent calcium or vitamin D deficiencies. Calcichew D3 500/400 will be compared to Adcal-D3 600/400 as prescribed in clinical practice and Calcichew D3 500/800 will be compared to Kalcipos-D 500/800 as prescribed in clinical practice.
This Crossover study will enroll approximately 276 patients equally divided between the two test groups (138 patients each). Within each test group, participants will be randomly assigned (by chance, like flipping a coin) to one of two treatment sequences, as described below.
Test Group 1:
Test Group 2:
Participants in Test Group 1 will take either Calcichew D3 500/400 or Adcal-D3 600/400 for 14 days and then will crossover to take either Calcichew D3 500/400 or Adcal-D3 600/400 treatment for 14 days. Participants in Test Group 2 will take either Calcichew D3 500/800 or Kalcipos-D 600/400 for 14 days and then will crossover to take either Calcichew D3 500/800 or Kalcipos-D treatment for 14 days.
This multi-center trial will be conducted In the United Kingdom and Germany. The overall time to participate in this study is 28 days. Participants will make multiple visits to the clinic including a final visit assessment at Day 28.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group 1: Sequence AB | Experimental | Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14, followed by Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, on Days 15 through 28. |
|
| Test Group 1: Sequence BA | Experimental | Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14, followed by, Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 15 through 28. |
|
| Test Group 2: Sequence CD | Experimental | Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14, followed by Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, once, daily, on Days 15 through 28. |
|
| Test Group 2: Sequence DC | Experimental | Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14, followed by, Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 15 through 28. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcichew D3 | Drug | Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Preference for Each Treatment Within Each Test Group | Preference was assessed by a 3 box questionnaire. Participants checked off one of the boxes: I prefer the first product that was tested, I prefer the second product that was tested or I have no preference. Test Group 1 (United Kingdom): Calcichew D3 is 500/400 and the comparator is Adcal-D3. Test Group 2 (Germany): Calcichew D3 is 500/800 and the comparator is Kalcipos-D. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Product Acceptability After Each 14 Day Dosing Period Within Each Test Group | Product acceptability was assessed by a 6 item questionnaire evaluating the characteristics of the product: gritty, chalky, sweet, ease of chew, ease of swallow and sticky. Using a 100 mm visual analog scale (VAS) the participant put a vertical line through each horizontal line that best describes their level of agreement with each item using a 0 to 100 scale where: 0=far left of the line (best) to 100= far right of the line (worst). Linear mixed model was used for analysis with treatment and period as fixed effects and participants as a random effect. |
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Inclusion Criteria:
In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
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.
Eligible participants will either be:
Is male or female.
A female participant 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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berlin | Germany | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27322906 | Derived | Thomasius F, Keung Nip T, Ivan P. Phase IV randomized preference study in patients eligible for calcium and vitamin D supplementation. Curr Med Res Opin. 2016 Oct;32(10):1623-1631. doi: 10.1080/03007995.2016.1202817. Epub 2016 Jun 29. |
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Participants eligible for Vitamin D and Calcium supplements were enrolled equally in 1 of 2 Test Groups to determine the preference between 2 treatments.
Group 1: Calcichew D3 500/400 and Adcal-D3 600/400 or Group 2: Calcichew D3 500/800 and Kalcipos-D 500/800.
Participants took part in the study at 9 investigative sites in the United Kingdom and Germany from 02 June 2015 to 27 August 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Group 1: Sequence AB | Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14, followed by Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, on Days 15 through 28. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
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| Adcal-D3 | Drug | Adcal-D3 (Calcium 600mg/400 IU Vitamin D3) |
|
| Kalcipos-D | Drug | Kalcipos-D (Calcium 500mg/800 IU Vitamin D3) |
|
| Day 14 and Day 28 |
| Product Tolerability Expressed as the Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event Within Each Test Group | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. | Day 1 to Day 28 |
| Bochum |
| Germany |
| Frankfurt | Germany |
| Leipzig | Germany |
| Reading | Berkshire | United Kingdom |
| Birmingham | United Kingdom |
| Chorley | United Kingdom |
| Liverpool | United Kingdom |
| Manchester | United Kingdom |
| Test Group 1: Sequence BA |
Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14, followed by, Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 15 through 28. |
| FG002 | Test Group 2: Sequence CD | Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14, followed by Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, once, daily, on Days 15 through 28. |
| FG003 | Test Group 2: Sequence DC | Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14, followed by, Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 15 through 28. |
| COMPLETED |
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| NOT COMPLETED |
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|
| Period 2 |
|
|
Randomized Analysis Set included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Group 1: Sequence AB | Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14, followed by Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, on Days 15 through 28. |
| BG001 | Test Group 1: Sequence BA | Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14, followed by, Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 15 through 28. |
| BG002 | Test Group 2: Sequence CD | Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14, followed by Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, once, daily, on Days 15 through 28. |
| BG003 | Test Group 2: Sequence DC | Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14, followed by, Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 15 through 28. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
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| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Height | Height data is available for 65, 70, 68 and 70 participants, respectively. | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
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| Body Mass Index (BMI) | BMI data is available for 65, 70, 68 and 70 participants, respectively. | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||
| BMI Categorical | Number | participants |
| ||||||||||||||||
| Smoking Status | Number | participants |
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| Alcohol Status | Number | participants |
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| History of Osteoporosis | Number | participants |
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| History of Osteopenia | Number | participants |
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| History of Fractures in the Last 10 Years | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With a Preference for Each Treatment Within Each Test Group | Preference was assessed by a 3 box questionnaire. Participants checked off one of the boxes: I prefer the first product that was tested, I prefer the second product that was tested or I have no preference. Test Group 1 (United Kingdom): Calcichew D3 is 500/400 and the comparator is Adcal-D3. Test Group 2 (Germany): Calcichew D3 is 500/800 and the comparator is Kalcipos-D. | All randomized participants from the Full Analysis Set (FAS) who received at least 1 dose of study medication and responded to the preference questionnaire. | Posted | Number | percentage of participants | Day 28 |
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| Secondary | Product Acceptability After Each 14 Day Dosing Period Within Each Test Group | Product acceptability was assessed by a 6 item questionnaire evaluating the characteristics of the product: gritty, chalky, sweet, ease of chew, ease of swallow and sticky. Using a 100 mm visual analog scale (VAS) the participant put a vertical line through each horizontal line that best describes their level of agreement with each item using a 0 to 100 scale where: 0=far left of the line (best) to 100= far right of the line (worst). Linear mixed model was used for analysis with treatment and period as fixed effects and participants as a random effect. | The FAS included all randomized participants. | Posted | Least Squares Mean | Standard Error | mm | Day 14 and Day 28 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Product Tolerability Expressed as the Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event Within Each Test Group | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. | The Safety Analysis Set included all randomized participants who received at least 1 dose of study medication. | Posted | Number | percentage of participants | Day 1 to Day 28 |
|
From first dose of the study drug to the last dose of study drug (Up to 28 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Safety Set included all participants who received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | United Kingdom: Calcichew D3 500/400 | Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28. | 1 | 135 | 1 | 135 | ||
| EG001 | United Kingdom: Adcal-D3 | Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28. | 0 | 136 | 5 | 136 | ||
| EG002 | Germany: Calcichew D3 500/800 | Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28. | 0 | 138 | 0 | 138 | ||
| EG003 | Germany: Kalcipos-D | Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28. | 0 | 138 | 0 | 138 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Clinical Science | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Significant Protocol Deviation |
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| Lost to Follow-up |
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| Voluntary Withdrawal |
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| ≥65 years |
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| From 65-84 Years |
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| 85 Years and Over |
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| Male |
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| Multiracial |
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| White |
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| Germany |
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| 25 to <30 kg/m^2 |
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| ≥30 kg/m^2 |
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| Missing |
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| Ex-smoker |
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| Current Smoker |
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| Ex-drinker |
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| Current Drinker |
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| No |
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| No |
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| No |
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| Preference for Comparator |
|
| No Preference |
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| OG003 | Germany: Kalcipos-D | Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28. |
|
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| OG003 | Germany: Kalcipos-D | Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28. |
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