Bone-Building drug under the microscope: could speed up new osteoporosis treatments
NCT ID NCT01293292
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked at how teriparatide (Forsteo), a daily injection, builds new bone in postmenopausal women with osteoporosis. Nineteen women took the drug for two years. The goal was not to test if it works, but to understand exactly how it changes bone density and turnover over time. This knowledge could help researchers develop and test new bone-building drugs faster.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Teriparatide (Forsteo)
- What this could lead to
- If successful, this study could help researchers develop new bone-building drugs for osteoporosis more quickly.
- What could go wrong
- This is a small, early-stage study with only 19 participants, so results may not apply to everyone. It focuses on understanding how the drug works, not on proving it is a cure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
19 people
The number who actually took part.
- Start date
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Jan 2011
- Finished
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Aug 2015
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Up to 84 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 use of glucocorticoid therapy * A corrected serum calcium less than 2.2 mmol/L and a PTH above 100 ng/L (that persists after testing and treatment for vitamin D deficiency) * A history of any known condition that would interfere with the assessment of DXA at either lumbar spine or femoral neck * Markedly abnormal clinical laboratory parameters that are assessed as clinically significant by the investigator * Any previous use of bisphosphonate * Use any of the following medications within 12 months of starting study drug * Any fluoride with the exception of use for oral hygiene * Strontium Ranelate * Other bone agents (e.g. SERM, isoflavones, HRT) * Participation in another clinical trial involving active therapy 3 months prior to enrolment * Less than 5 years since menopause * Bilateral fractures in the measurement regions (hip, tibia and forearm) * Recent fracture within the last 12 months * Prior radiation therapy which may involve the skeleton * Hypersensitivity to teriparatide or any of its excipients * Unexplained elevations of alkaline phosphatase * Any known contraindication to the use of teriparatide
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S5 7AU, United Kingdom
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Other studies related to the condition(s) this trial covers.
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