How well women with postmenopausal osteoporosis stick to bisphosphonates plus calcium and vitamin D
Observational, Cross-sectional, Multicenter Study to Evaluate Adherence to Different Treatment Regimens With Oral Bisphosphonates and Calcium and Vitamin D Supplements in Postmenopausal Osteoporosis.
This project will see how well postmenopausal women taking monthly or weekly oral bisphosphonates together with daily calcium and vitamin D keep taking their medicines using one clinic visit and three short questionnaires.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 480 (estimated) |
| Sex | Female |
| Sponsor | Procare Health Iberia S.L. Industry-sponsored |
| Locations | 21 sites (Santiago de Compostela, A coruña and 20 other locations) |
| Trial ID | NCT07105163 on ClinicalTrials.gov |
What this trial studies
This is an observational one-visit study in which participants attend a routine follow-up appointment and provide information from their medical history. During that visit investigators will administer three questionnaires that ask how and how often patients take their bisphosphonate and daily calcium/vitamin D supplements, about missed doses, and satisfaction with current treatment. Eligible participants are postmenopausal women who have been prescribed oral monthly or weekly bisphosphonates plus daily calcium/vitamin D for at least six months. No experimental treatments are given and data are collected purely by interview and chart review.
Who should consider this trial
Good fit: Postmenopausal women with a diagnosis of osteoporosis who have been on oral monthly or weekly bisphosphonates plus daily calcium and vitamin D for at least six months and can provide informed consent.
Not a fit: Women not taking oral monthly/weekly bisphosphonates with daily calcium/vitamin D, those on IV bisphosphonates, or those on therapy for less than six months are unlikely to get direct benefit from this study.
Why it matters
Potential benefit: If the findings identify common barriers to taking medicine, clinics could use that information to support patients and reduce fracture risk.
How similar studies have performed: Previous observational studies have repeatedly shown suboptimal long-term adherence to bisphosphonates and supplements, so this approach is common and builds on established findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. \- Women diagnosed with postmenopausal OP. 2. \- Women who had been prescribed oral treatment with a BP administered monthly or weekly together with a Ca/D supplement (sachets or chewable tablets) administered daily, at least 6 months prior to inclusion in the study. 3. \- Women who had given their written informed consent before participating in the study. Exclusion Criteria: None
Where this trial is running
Santiago de Compostela, A coruña and 20 other locations
- Clinica Gaias Santiago — Santiago de Compostela, A coruña, Spain (Recruiting)
- CP Dr Caracuel — Córdoba, Andalusia, Spain (Recruiting)
- Hospital Reina Sofia — Córdoba, Andalusia, Spain (Recruiting)
- Hospital Virgen del Rocio — Seville, Andalusia, Spain (Recruiting)
- CP Dr Agramonte — Palma de Mallorca, Balearic Islands, Spain (Recruiting)
- CP Dr Balta — Palma de Mallorca, Balearic Islands, Spain (Recruiting)
- CHU Insular - H Materno-Infantil — Las Palmas de Gran Canaria, Canary Islands, Spain (Recruiting)
- CHU Insular - H Materno-Infantil — Las Palmas de Gran Canaria, Canary Islands, Spain (Recruiting)
- Hospital Zamora — Zamora, Castille and León, Spain (Recruiting)
- Clinica Sagrada Familia — Barcelona, Catalonia, Spain (Recruiting)
- CP Dra Sanchez — Barcelona, Catalonia, Spain (Recruiting)
- Hospital del Mar — Barcelona, Catalonia, Spain (Recruiting)
- Hospital del Tajo — Aranjuez, Madrid, Spain (Recruiting)
- CP Dr Solano — Madrid, Madrid, Spain (Recruiting)
- CP Dr Zafra — Madrid, Madrid, Spain (Recruiting)
- CP Dra Gerechter — Madrid, Madrid, Spain (Recruiting)
- Hospital Infanta Leonor — Madrid, Madrid, Spain (Recruiting)
- Hospital Virgen del Mar — Madrid, Madrid, Spain (Recruiting)
- CP Dr Larrauri — Vigo, Pontevedra, Spain (Recruiting)
- CP Dra Medrano — Alicante, Valencia, Spain (Recruiting)
- CP Dra Tejon — Alicante, Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Josep Combalia
- Email: combalia.j@procarehealth.com
- Phone: 0034 93 645 54 51
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.