Calcium supplements for the prevention of osteoporosis in perimenopausal women
| ISRCTN | ISRCTN83573042 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83573042 |
| Secondary identifying numbers | PROP-02A |
- Submission date
- 15/01/2019
- Registration date
- 07/03/2019
- Last edited
- 08/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Osteoporosis is a bone disease that occurs when the body loses too much bone, makes too little bone, or both. As a result, bones become weak and may break from a fall.
Frequently, calcium supplements are recommended for the prevention or the treatment of the osteoporosis.
The main objective of the present study is to confirm whether the treatment with the ossein-hydroxyapatite complex, a calcium supplement, is better tolerated than the treatment with calcium carbonate, another calcium supplement.
Who can participate?
Women in the perimenopausal period.
Perimenopause takes place over several years in advance of the menopause and can last for 4 to 8 years. Thus, women between 40 and 50 years that are in the perimenopausal period, according to their physicians, are included in the study.
Women with normal bone density or slightly reduced (what is called osteopenia) are included in the study.
What does the study involve?
As the study compares two different calcium supplements, a group of participants is treated with 2 tablets every 12 hours of ossein-hydroxyapatite complex, a calcium supplement, and the other with 1 tablet every 12 hours of calcium carbonate, another calcium supplement. In all the patients the treatment is taken through the mouth. The treatment will last for three years.
What are the possible benefits and risks of participating?
Participants enrolled in this study are receiving a treatment that could help them to prevent osteoporosis.
The studied treatments are usually well tolerated. Nevertheless, some people could have constipation, mild nausea, diarrhoea, abdominal disturbances and, very rarely, itchy skin.
Where is the study run from?
The study has been developed in different health centers in an outpatient setting, previously specified, of several Spanish cities (A Coruña, Alicante, Badajoz, Barcelona, Bilbao, Santander, Castellón, Guadalajara, Las Palmas, León, Lugo, Madrid, Murcia Tarragona, Valencia, Zamora and Zaragoza).
When is the study starting and how long is it expected to run for?
The study begun in 2002 and patient inclusion finished in 2008.
Who is funding the study?
The study is funded by Pierre Fabre Ibérica S.A.
Who is the main contact?
José Manasanch
(jose.manasanch@pierre-fabre.com)
Contact information
Scientific
Ramon Trias Fargas, 7-9
Barcelona
08005
Spain
 ORCID ID |
0000-0003-3633-8778 |
|---|
Study information
| Study design | Observational, multicentre, prospective, open-label, comparative study with a follow-up of three years. |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | No participant information sheet available. |
| Scientific title | Pharmacovigilance observational study of two calcium supplements in the prophylaxis of the osteoporosis in the perimenopause: a longitudinal study |
| Study acronym | PROP |
| Study objectives | To confirm that ossein-hydroxyapatite complex shows a higher tolerability than calcium carbonate. |
| Ethics approval(s) | The study did not require ethics approval at the time of initiation as in 2002, in Spain, ethics approval was not mandatory for observational studies related to pharmacovigilance using registered and marketed calcium supplements in an approved indication. It was approved by the Spanish Medicines Agency, Ministry of Health on the 05/03/2002. |
| Health condition(s) or problem(s) studied | Osteopenia |
| Intervention | Patients in the ossein-hydroxyapatite complex (OHC) arm took two tablets of OHC every 12 hours (830 mg OHC per tablet), by oral route, along three years. Patients in the calcium carbonate (CC) group took one tablet every 12 hours (1,250 CC mg per tablet), by oral route, along three years. As an observational study, carried out in the real-world practice, there were no randomisation. |
| Intervention type | Supplement |
| Primary outcome measure | Measured using patient interview at follow-up visits every 6 months for 3 years: 1. The number of patients with at least one adverse reaction 2. The severity of the adverse reaction. 3. The relationship of the adverse reaction with the study medication 4. The actions taken in response to the adverse reaction. 5. The outcome of the adverse reaction. 6. The duration of the adverse drug reaction |
| Secondary outcome measures | 1. Bone mineral density was measured by DEXA every 18 months. 2. BMI (kg/m2) was measured every 18 months. 3. The waist hip ratio (%) was measured every 18 months. 4. Lipid metabolism was measured using laboratory analytical data yearly. 5. Bone fractures taking place during the study period were registered at each 6-month follow-up visit. 6. Climacteric (menopausal) symptom changes were measured using the GEM scale every 18 months. 7. Treatment compliance was assessed by means of patient interview at each follow-up (every 6 months). |
| Overall study start date | 03/09/2001 |
| Completion date | 12/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Initially 1,024 patients were expected to be included in the study. |
| Key inclusion criteria | 1. Patients with an indication for the use of CC or OHC according to the investigator criteria. 2. Perimenopausal women between 40 and 50 years old. 3. Patients treated in an outpatient setting. |
| Key exclusion criteria | 1. Patients with severe osteopenia (diagnosed by DEXA, bone mineral density [BMD] ≤ -2 standard deviation [SD] T-score) or osteoporosis (BMD ≤ -2.5 SD T score) 2. Patients who were being treated with a drug that could have compromised bone metabolism such as: glucocorticoids, steroids, thyroid hormones, heparins (in long-term treatment), anticonvulsants, anovulatory drugs, hormone replacement therapy, lithium, chemotherapy, selective estrogen-receptor modulator (SERM), immunosuppressive therapy, and bisphosphonates. A minimal washout period of 6 months was established for any of the previous treatments prior to including the patient in the study. 3. Patients with severe hypercalcaemia or hypercalciuria. 4. Pregnant patients. 5. Concomitant diseases that could have affected bone metabolism: acromegaly, hyperthyroidism, primary hyperparathyroidism, anorexia nervosa, Cushing’s syndrome, rheumatoid arthritis, renal diseases, renal lithiasis, diabetes mellitus, and chronic liver disease. 6. Concomitant metabolic bone disease: osteomalacia, Paget’s disease. 7. Neoplastic disease developed in the last 5 years, with the exception of skin neoplasias treated with a radical treatment. 8. Known allergy to any compound of the study drugs. 9. Gastrointestinal disorders that could interfere with drug absorption. 10. Women with an expected difficult follow-up due to psychological, cognitive or social circumstances. 11. Patients with foreseen low compliance, difficult follow-up and/or poor collaboration, or with foreseen risk of withdrawal over a minimum period of 3 months due to dementia, alcoholism, terminal illness, etc. |
| Date of first enrolment | 25/07/2002 |
| Date of final enrolment | 02/06/2011 |
Locations
Countries of recruitment
- Spain
Study participating centres
A Coruña
15011
Spain
Alicante
03010
Spain
Alcoy
03804
Spain
Alicante
03600
Spain
Alicante
03002
Spain
Don Benito
06400
Spain
Barcelona
08036
Spain
Barcelona
08003
Spain
Barcelona
08940
Spain
Barcelona
08911
Spain
Castelldefels
08860
Spain
Barcelona
08930
Spain
Barcelona
08023
Spain
Bilbao
48010
Spain
Santander
39008
Spain
Castellón
12001
Spain
Castellón
12004
Spain
Guadalajara
19002
Spain
Las Palmas G. Canaria
35016
Spain
Las Palmas G. Canaria
35007
Spain
León
24008
Spain
Lugo
27004
Spain
Madrid
28009
Spain
Madrid
28046
Spain
Madrid
28029
Spain
Móstoles
28934
Spain
Madrid
28047
Spain
Torrelodones
28250
Spain
Madrid
28905
Spain
Madrid
28009
Spain
Madrid
28034
Spain
Murcia
30001
Spain
Tarragona
43005
Spain
Valencia
46021
Spain
Valencia
46006
Spain
Valencia
46015
Spain
Valencia
46021
Spain
Alzira
46600
Spain
Torrent
46900
Spain
Valencia
46021
Spain
Valencia
46010
Spain
Zamora
49010
Spain
Zaragoza
50005
Spain
Zaragoza
50006
Spain
Zaragoza
50004
Spain
Sponsor information
Other
Sicomoro, 11
Getafe
28903
Spain
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 21/06/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results about safety and efficacy are intended to be published, along 2019, in a peer-reviewed medicine journal addressed to clinicians of several specialities. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from José Manasanch, jose.manasanch@pierre-fabre.com. The data (raw data and statistical analysis) will become available as soon as the results will be published and could be requested for a minimum of three years after this date if needed for investigational purposes. A formal request will be necessary. Patients meeting the selection criteria were included in the study after providing informed consent that remain in the investigator files. Any data from the patients was anonymized from inclusion in the study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | results presented at EMAS Congress : | 01/05/2015 | No | No | |
| Basic results | 22/01/2019 | No | No |
Additional files
Editorial Notes
08/03/2019: Internal review.
07/03/2019: The basic results of this trial have been uploaded as an additional file
