NCT07105163

Brief Summary

This study aims to evaluate the adherence of patients to combined treatment with bisphosphonates and calcium and vitamin D supplements, which is one of the usual treatments for postmenopausal osteoporosis. The study will consist of a single visit that will coincide with one of the patient's usual follow-up visits according to standard clinical practice. During this visit, information will be collected from the patient's medical history and an interview will be conducted using 3 questionnaires to assess how and how often the patient takes the treatment, possible forgetfulness, and whether or not the patient is satisfied with their current treatment.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

21 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 5, 2025

Status Verified

July 1, 2025

Enrollment Period

9 months

First QC Date

June 30, 2025

Last Update Submit

July 29, 2025

Conditions

Keywords

ProcarePost menopausal osteoporosisBisphosphonatecalciumvitamin Dsupplement

Outcome Measures

Primary Outcomes (1)

  • Intergroup adherence

    To evaluate intergroup adherence to the most common oral regimens used in the treatment of postmenopausal OP that combine BP and Ca/D supplements, using a 8-items Morisky Medication Adherence Scale

    Day 1

Secondary Outcomes (6)

  • Persistence intergroup

    Day 1

  • Adherence intragroup

    Day 1

  • Persistence intragroup

    Day 1

  • Factors of non-adherence

    Day 1

  • Factors of non-persistence

    Day 1

  • +1 more secondary outcomes

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with postmenopausal osteoporosis who have been prescribed treatment with an oral bisphosphonate combined with Ca/D supplements.

You may qualify if:

  • \- Women diagnosed with postmenopausal OP.
  • \- Women who had given their written informed consent before participating in the study.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

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

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2025

First Posted

August 5, 2025

Study Start

March 3, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

August 5, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations