Condition category
Musculoskeletal Diseases
Date applied
24/04/2008
Date assigned
09/06/2008
Last edited
09/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Willem Lems

ORCID ID

Contact details

Vrije University Medical Centre
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands
wf.lems@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CW-004-IN

Study information

Scientific title

Acronym

Study hypothesis

The aim of this trial was to assess the preference for a formulation based on the identification of some of the factors that may influence compliance with the intake of calcium plus vitamin D3 supplements.

Ethics approval

Ethics approval received from the Local Ethical Committee in February 2003.

Study design

Randomised, open, cross-over clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Osteoporosis

Intervention

The Calci-Chew D3 chewable tablets (Nycomed, Denmark) contained 1250 mg of calcium carbonate (equivalent to 500 mg elemental calcium) and 400 IU of cholecalciferol (equivalent to 10 µg vitamin D3). The sachet of calcium plus vitamin D3 (Cad, Will-Pharma) contained 1250 mg of calcium carbonate (equivalent to 500 mg elemental calcium) and 440 IU of vitamin D3.

The patients received both trial medications for 14 days, which was considered adequate for a patient to become familiar with the formulation and to assess the preference and acceptability. The patients received either the chewable tablet for two weeks followed by the sachet for two weeks or vice versa.

Total duration follow-up: 28 weeks

Intervention type

Supplement

Phase

Not Specified

Drug names

Calcium, vitamin D3 supplementation

Primary outcome measures

To assess any preference between Calci-Chew D3 and Cad, measured at visit 3 (day 28).

Secondary outcome measures

1. To compare acceptability of the formulations using an 11-point rating scale, measured at visit 2 (day 14) and visit 3 (day 28)
2. To record tolerability and adverse events, measured at visit 2 (day 14) and visit 3 (day 28)

Overall trial start date

01/02/2003

Overall trial end date

30/11/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with osteoporosis who required calcium and vitamin D supplementation as part of their anti-osteoporotic therapy
2. Age range: greater than 18 years, gender: women and men

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Use of the trial medications during the past six months
2. Any condition for which the trial medications are contra-indicated, such as hypercalcaemia, hypercalciuria, Zollinger-Ellison syndrome, and nephrolithiasis
3. Use of drugs known to interact with the trial medications (e.g., digoxin, tetracycline, fluoroquinolones, bisphosphonates, iron, sodium fluoride, diuretics, phenytoin, barbiturates, corticosteroids, levothyroxine, ion exchange resins, laxatives)
4. Planned surgery during the four-week study period
5. Pregnant, possibly pregnant, or breastfeeding women

Recruitment start date

01/02/2003

Recruitment end date

30/11/2003

Locations

Countries of recruitment

Netherlands

Trial participating centre

Vrije University Medical Centre
Amsterdam
1081 HV
Netherlands

Sponsor information

Organisation

Nycomed (Denmark)

Sponsor details

Langebjerg 1
Roskilde
DK-4000
Denmark
Info@nycomed.com

Sponsor type

Industry

Website

http://www.nycomed.com/en/menu/

Funders

Funder type

Industry

Funder name

Nycomed (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes