Post Menopausal OsteoporosisOSTEOADNCT07105163
Evaluation of Adherence With Bisphosphonates and Calcium and Vitamin D Supplements in Women With Postmenopausal Osteoporosis
An observational study of Post Menopausal Osteoporosis, run by Procare Health Iberia S.L. at 20 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Post Menopausal Osteoporosis
- How many people
- 230 participants
- Where
- 20 sitesSpain
- Study dates
- 3 Mar 2025to 3 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women with postmenopausal osteoporosis who have been prescribed treatment with an oral bisphosphonate combined with Ca/D supplements.
Who may be able to join
- - Women diagnosed with postmenopausal OP.
- - 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.
- - Women who had given their written informed consent before participating in the study.
Who cannot join
- None
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Spain20 sites
CP Dra Medrano
Alicante, Valencia
CP Dra Tejon
Alicante, Valencia
Hospital del Tajo
Aranjuez, Madrid
Clinica Sagrada Familia
Barcelona, Catalonia
CP Dra Sanchez
Barcelona, Catalonia
Hospital del Mar
Barcelona, Catalonia
CP Dr Caracuel
Córdoba, Andalusia
Hospital Reina Sofia
Córdoba, Andalusia
CHU Insular - H Materno-Infantil
Las Palmas de Gran Canaria, Canary Islands
CP Dr Solano
Madrid, Madrid
CP Dr Zafra
Madrid, Madrid
CP Dra Gerechter
Madrid, Madrid
Hospital Infanta Leonor
Madrid, Madrid
Hospital Virgen del Mar
Madrid, Madrid
CP Dr Agramonte
Palma de Mallorca, Balearic Islands
CP Dr Balta
Palma de Mallorca, Balearic Islands
Clinica Gaias Santiago
Santiago de Compostela, A coruña
Hospital Virgen del Rocio
Seville, Andalusia
CP Dr Larrauri
Vigo, Pontevedra
Hospital Zamora
Zamora, Castille and León
About this study
Official title: 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 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.
- Conditions
- Post Menopausal Osteoporosis
- Keywords
- Procare, Post menopausal osteoporosis, Bisphosphonate, calcium, vitamin D, supplement
- Medical subject headings
- Osteoporosis, Postmenopausal
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (6)
Persistence intergroup
To evaluate, intergroup, the persistence to the most common oral regimens used in the treatment of postmenopausal OP that combine BP and Ca/D supplements. It will be evaluated over time from the start of the combination of both until the first end date of administration of either one, and by the percentage of patients who continue with the combined treatment since its prescription
Measured: Day 1
Adherence intragroup
To evaluate, intragroup, the adherence to the prescribed usual oral regimens, using a 8-items Morisky Medication Adherence Scale
Measured: Day 1
Persistence intragroup
To evaluate, intragroup, the persistence to the prescribed usual oral regimens.
Measured: Day 1
Factors of non-adherence
To evaluate possible determining factors of non-adherence to the prescribed usual oral regimens and their comparison between the different regimens.
Measured: Day 1
Factors of non-persistence
To evaluate possible determining factors of non-persistence to the prescribed usual oral regimens and their comparison between different regimens.
Measured: Day 1
Treatment satisfaction
To evaluate the patient's satisfaction with the combined treatment received using a Likert scale.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start3 Mar 2025
- Primary completion3 Dec 2025
- Study completion3 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Menopausal OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procare Health Iberia S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105163
- Sponsor's protocol ID
- OSTEOAD
- Acronym
- OSTEOAD
- Status last verified
- Oct 2026
- First submitted
- 30 Jun 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Cross-sectional, Multicenter Study to Evaluate Adherence to Different Treatment Regimens With Oral Bisphosphonates and Calcium and Vitamin D Supplements in Postmenopausal Osteoporosis.
- ClinicalTrials.gov ID
- NCT07105163
- Acronym / sponsor ID
- OSTEOAD / OSTEOAD
- Conditions
- Post Menopausal Osteoporosis
- Keywords
- Procare, Post menopausal osteoporosis, Bisphosphonate, calcium, vitamin D, supplement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Procare Health Iberia S.L.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 3 Dec 2025 (actual)
- Study completion
- 3 Dec 2025 (actual)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women with postmenopausal osteoporosis who have been prescribed treatment with an oral bisphosphonate combined with Ca/D supplements.
Key inclusion criteria (3 listed)
- - Women diagnosed with postmenopausal OP.
- - 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.
- - Women who had given their written informed consent before participating in the study.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intergroup adherence
Time frame: Day 1
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
6 secondary outcomes
Persistence intergroup
Time frame: Day 1
Adherence intragroup
Time frame: Day 1
Persistence intragroup
Time frame: Day 1
Factors of non-adherence
Time frame: Day 1
Factors of non-persistence
Time frame: Day 1
Treatment satisfaction
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Menopausal Osteoporosis, run by Procare Health Iberia S.L. at 20 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intergroup adherence (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.