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Osteoporosis drug may strengthen bones from the inside out

NCT ID NCT01155232

Disease control Sponsor: University Health Network, Toronto Source: ClinicalTrials.gov ↗

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether taking teriparatide (Forteo) for 24 months can improve bone structure in 100 men and women with osteoporosis. Researchers will use a special CT scan to see changes in bone thickness and microarchitecture at the wrist and shin. The goal is to understand how this drug reduces fracture risk beyond just increasing bone density.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Teriparatide (Forteo) injection
What this could lead to
If successful, this could show that teriparatide strengthens bones by improving their internal structure, not just density, leading to better fracture prevention.
What could go wrong
This is a small, non-randomized study with 100 participants, so results may not apply to everyone. Bone structure changes may not translate to fewer fractures.

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.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Nov 2004

Expected to finish

Jan 2028

An estimate. End dates often move.

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.

Who is studied

community dwelling men and women with osteoporosis who have been prescribed teriparatide for severe osteoporosis. (Teriparatide is not supplied as part of this study)

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

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: * History of fragility fracture OR * High risk for fractures OR * Very low BMD (T-score ≤ -2.5) OR * Failed or intolerant to bisphosphonates * Baseline serum levels of calcium, urate, ALP, PTH, creatinine and 25- hydroxyvitamin D \[25(OH)D\] must be within acceptable normal limits * Ability to obtain teriparatide (not supplied by study sponsor) Exclusion Criteria: * History of skeletal irradiation * Those at increased risk for osteosarcoma * Diagnosis of Paget's disease * History of primary hyperparathyroidism * Significant renal impairment * Vitamin D deficiency * On steroids or have other causes of secondary osteoporosis

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Conditions

The condition(s) this trial relates to.

osteoporosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteoporosis

Contacts and locations

Locations

  • University Health Network, TGH

    Toronto, Ontario, M5G 2C4, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.