CompletedNot Applicable

Effects of Physical Training on Bone Turnover and Quality of Life in Osteopenic Postmenopausal Women.

33 participantsStarted 2015-05

Plain-language summary

The aim of our research was to define both in vivo and in vitro whether and to what extent an high-impact exercise program would affect bone cell turnover and improve the QoL in osteopenic postmenopausal women.

Who can participate

Age range

52 Years – 70 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * postmenopausal * bone mineral density T-score less than -1 but more than -2.5 in the total hip or lumbar spine (L1-L4) by dual energy x-ray absorptiometry * be able to attend an exercise program 2 times per week over the 3-month period * stated availability throughout the entire study period Exclusion Criteria: * secondary causes of bone loss such as osteomalacia, glucocorticoid medication * co-morbidities that would interfere with participation in exercise such as severe heart or pulmonary disease, inflammatory joint disease, severe osteoarthritis, psychiatric condition * physical or orthopaedic disabilities that would place the subject at risk or limit their ability to perform exercise * a past vertebral fracture * history of chronic diseases, such as renal, hepatic, cardiac, and rheumatic diseases * current or prior use of drugs that could interfere with bone mass (i.e. glucocorticoids, antiresorptive drugs and hormonal replacement therapy)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP)

Timeframe: Baseline - Week 4

Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP).

Timeframe: Week 4 - Week 12

Serum Sclerotin Levels

Timeframe: Baseline - W4

Sclerostin

Timeframe: Week 4 - Week 12

Variation in Serum Carboxy-terminal Telopeptide of Collagen Type I (sCTX)

Timeframe: Baseline - Week 4

Variation of Serum Carboxy Terminal Telopeptide of Collagen Type I (sCTX)

Timeframe: Week 4 - Week 12

Variation in Circulating Osteoprogenitor Cells (OPCs)

Timeframe: Baseline - Week 4

Trial details

NCT IDNCT03195517

SponsorUniversity Of Perugia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-03

Results submitted2017-10-31

View on ClinicalTrials.gov More Osteopenia trials

Who can participate

Age range

52 Years – 70 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP)

Timeframe: Baseline - Week 4

Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP).

Timeframe: Week 4 - Week 12

Serum Sclerotin Levels

Timeframe: Baseline - W4

Sclerostin

Timeframe: Week 4 - Week 12

Variation in Serum Carboxy-terminal Telopeptide of Collagen Type I (sCTX)

Timeframe: Baseline - Week 4

Variation of Serum Carboxy Terminal Telopeptide of Collagen Type I (sCTX)

Timeframe: Week 4 - Week 12

Variation in Circulating Osteoprogenitor Cells (OPCs)

Timeframe: Baseline - Week 4