Osteoporosis, PostmenopausalOsteo_womenNCT03091088
Effects of Physical Exercise to Prevent Osteoporosis in Postmenopausal Women
A study testing walking at an intense pace and osteoporosis specific-oriented training in people with Osteoporosis, Postmenopausal and Osteoporosis, Osteopenia, run by University of Valencia.
Trial summary
According to the World Health Organization criteria, osteoporosis was defined as a bone mineral density that lies 2.5 standard deviations or more below the average value for young healthy women. Osteoporosis is a major cause of fractures and can lead to serious complications in postmenopausal women. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Postmenopausal, Osteoporosis, Osteopenia, Physical Activity
- What is being tested?
- walking at an intense pace and osteoporosis specific-oriented training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2011to 30 Dec 2016
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal woman
- Pharmacological treatment (VitaminD+Calcium)
Who cannot join
- Disease or physical-mental condition which prevents to perform the proposed physical exercise
About this study
Official title: Efecto de Dos Tipos de Ejercicio físico Para Prevenir la Osteoporosis en Mujeres Postmenopausicas, un Ensayo Clinico Aleatorizado
According to the World Health Organization criteria, osteoporosis was defined as a bone mineral density that lies 2.5 standard deviations or more below the average value for young healthy women. Osteoporosis is a major cause of fractures and can lead to serious complications in postmenopausal women. For this reason, approaches to prevent the appearance and progression of osteoporosis are of primary importance. This randomized clinical trial analyzes the effects of two types of physical exercise oriented to prevent osteoporosis in postmenopausal women with pharmacological supplements of Calcium and Vitamin-D.
- Being tested
- walking at an intense pace, osteoporosis specific-oriented training
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis, Bone Diseases, Metabolic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walking at an intense paceOther
Participants walk 6 kilometers in 1 hour at least 3 times per week
osteoporosis specific-oriented trainingOther
1 hour of physical activity, 2 times per week, based on the Asociación Española con la Osteoporosis y la Artrosis (AECOS) recommendations. Sessions are divided in 15 minutes of warmup (8 to 10, 60-second exercises), 30-35 minutes of combined exercises with loads and weights, as well as high intensity exercises, and 10-15 minutes of cooldown activities (based on Frederick relaxation techniques)
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | walking at an intense pace Receives: Other: walking at an intense pace |
| Experimental | Experimental | osteoporosis specific-oriented training Receives: Other: osteoporosis specific-oriented training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral neck T-score
The score compares femoral neck bone mineral density to a reference mean
Measured: Change from baseline score at two years
Lumbar spine T-score
The score compares lumbar spine bone mineral density to a reference mean
Measured: Change from baseline score at two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start1 Feb 2011
- Primary completion1 Jul 2013
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CARMEN GARCÍA GOMARIZ, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091088
- Sponsor's protocol ID
- ID_OW
- Acronym
- Osteo_women
- Status last verified
- Mar 2017
- First submitted
- 14 Mar 2017
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Garcia-Gomariz C, Blasco JM, Macian-Romero C, Guillem-Hernandez E, Igual-Camacho C. Effect of 2 years of endurance and high-impact training on preventing osteoporosis in postmenopausal women: randomized clinical trial. Menopause. 2018 Mar;25(3):301-306. doi: 10.1097/GME.0000000000001005.
PubMed 29040219
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efecto de Dos Tipos de Ejercicio físico Para Prevenir la Osteoporosis en Mujeres Postmenopausicas, un Ensayo Clinico Aleatorizado
- ClinicalTrials.gov ID
- NCT03091088
- Acronym / sponsor ID
- Osteo_women / ID_OW
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Feb 2011 (actual)
- Primary completion
- 1 Jul 2013 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 27 Mar 2017 (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.
According to the World Health Organization criteria, osteoporosis was defined as a bone mineral density that lies 2.5 standard deviations or more below the average value for young healthy women. Osteoporosis is a major cause of fractures and can lead to serious complications in postmenopausal women. For this reason, approaches to prevent the appearance and progression of osteoporosis are of primary importance. This randomized clinical trial analyzes the effects of two types of physical exercise oriented to prevent osteoporosis in postmenopausal women with pharmacological supplements of Calcium and Vitamin-D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: walking at an intense pacewalking at an intense pace |
| Experimental | Experimental | Other: osteoporosis specific-oriented trainingosteoporosis specific-oriented training |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal woman
- Pharmacological treatment (VitaminD+Calcium)
Key exclusion criteria (1 listed)
- Disease or physical-mental condition which prevents to perform the proposed physical exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| walking at an intense paceParticipants walk 6 kilometers in 1 hour at least 3 times per week | Other | Control |
| osteoporosis specific-oriented training1 hour of physical activity, 2 times per week, based on the Asociación Española con la Osteoporosis y la Artrosis (AECOS) recommendations. Sessions are divided in 15 minutes of warmup (8 to 10, 60-second exercises), 30-35 minutes of combined exercises with loads and weights, as well as high intensity exercises, and 10-15 minutes of cooldown activities (based on Frederick relaxation techniques) | Other | Experimental |
Primary outcome
Femoral neck T-score
Time frame: Change from baseline score at two years
The score compares femoral neck bone mineral density to a reference mean
Lumbar spine T-score
Time frame: Change from baseline score at two years
The score compares lumbar spine bone mineral density to a reference mean
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 27 Mar 2017.
- Derived from this study: PubMed 29040219Garcia-Gomariz C, Blasco JM, Macian-Romero C, Guillem-Hernandez E, Igual-Camacho C. Effect of 2 years of endurance and high-impact training on preventing osteoporosis in postmenopausal women: randomized clinical trial. Menopause. 2018 Mar;25(3):301-306. doi: 10.1097/GME.0000000000001005.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing walking at an intense pace and osteoporosis specific-oriented training in people with Osteoporosis, Postmenopausal and Osteoporosis, Osteopenia, run by University of Valencia.
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 2 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 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Femoral neck T-score (time frame: Change from baseline score at two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03091088, which also lists 1 linked publication.
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 27 Mar 2017.