Patient preference and acceptability of calcium plus vitamin D3 supplementation: a randomised, open, cross-over trial

Not Applicable

Completed

• Conditions: Osteoporosis; Musculoskeletal Diseases; Osteoporosis without pathological fracture

• Registration Number: ISRCTN18822358
• Lead Sponsor: ycomed (Denmark)

Brief Summary

2010 results in https://pubmed.ncbi.nlm.nih.gov/20033244/ (added 30/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2003-11-30
• Study Start: 2008-06-09
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 102

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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