Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of Action (NCT01293292) | Clinical Trial Compass
CompletedPhase 4
Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of Action
United Kingdom19 participantsStarted 2011-01
Plain-language summary
Previously the approach to treatment of osteoporosis has been to use medications which prevent excessive resorption of bone. More recently medications that build up new bone, i.e. anabolic treatments, have been, and are being, developed. The investigators would like to develop a strategy for evaluating the effectiveness of anabolic therapies by studying a currently available therapy (teriparatide). This strategy could then be used to assess new anabolic treatments as they are developed for use in humans.
The aims of this study are 1) to fully describe the changes in bone turnover in response to teriparatide by biochemical marker type and by time; 2) to fully describe the changes in bone mineral density (BMD) in response to teriparatide by site, bone compartment and time.
If this study is able to identify an early response to treatment, then this will help speed up drug development in this area, by allowing the identification of promising new anabolic drugs and enabling us to understand their mechanism of action. This will benefit the investigators patients as the investigators will have a better understanding of how these drugs work.
Who can participate
Age range
84 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
Subjects must:
* Have a bone mineral density T-score (at the lumbar spine or total hip) of less than or equal to -2.5
* Be female
* Be at least 5 years post menopausal (more than 5 years since their last menstrual period) but \<85 years old.
* Be ambulatory
* Be able and willing to participate in the study and provide written informed consent
* Have a serum 25(OH)2 vitamin D3 \>50 nmol/L (after vitamin D3 loading)
Exclusion Criteria
Patients will not be admitted to the study if they exhibit any of the following:
* Evidence of a clinically significant organic disease which could prevent the patient from completing the study
* A body mass index less than 18 or greater than 35
* Abuse of alcohol or use illicit drugs (information obtained from medical history) or who consumed more than 4 servings of any alcoholic beverage one day prior to the visit (i.e., subjects who might be binge drinkers)
* Any history of cancer within the past 5 years excluding skin cancer non melanomas
* Any history of ongoing conditions or diseases known to cause abnormalities of calcium metabolism or skeletal health including Paget's disease of bone
* Chronic renal disease (as defined by an estimated glomerular filtration rate of ≤ 30mL/min)
* Acute or chronic hepatic disease
* Malabsorption syndromes
* Hyperthyroidism as manifested by TSH outside the lower limit of the normal range
* Hyperparathyroidism
* Hypocalcemia or hypercalcemia
* Osteomalacia
* Cushing's syndrome
* Current …
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
1
Volumetric bone mineral density (BMD) of the lumbar spine (mg hydroxyapatite/cm3)
Timeframe: 0 to 104 weeks
Trial details
NCT IDNCT01293292
SponsorSheffield Teaching Hospitals NHS Foundation Trust