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Bone-Building drug under the microscope: could speed up new osteoporosis treatments

NCT ID NCT01293292

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Jan 2011

Finished

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

Up to 84 years

Sex

Female participants only

Healthy volunteers

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

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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