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Brittle bone breakthrough? new drug combo aims to cut fractures

NCT ID NCT03735537

Disease control Sponsor: University of Edinburgh 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a two-year course of teriparatide (a bone-building drug) followed by a single infusion of zoledronic acid (a bone-strengthening drug) could reduce fractures in adults with osteogenesis imperfecta, also known as brittle bone disease. 350 participants were randomly assigned to receive either this drug combination or standard care. The main goal was to see if fewer people in the drug group experienced a broken bone.

What this could mean

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

Active substance
teriparatide (a bone-building drug) and zoledronic acid (a bone-strengthening drug)
What this could lead to
If it works, this could provide a new treatment option to reduce fractures in adults with brittle bone disease.
What could go wrong
This is a completed phase 4 trial, but results may not apply to all types of osteogenesis imperfecta. The treatment involves two drugs with potential side effects like bone pain or kidney issues.

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

350 people

The number who actually took part.

Started

Nov 2016

Finished

Mar 2025

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

18 years and older

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: * Adult patients aged 18 years and over with a clinical diagnosis of Osteogenesis Imperfecta (OI) * Patients willing and able to consent and comply with the study protocol Exclusion Criteria: * Current or previous treatment with an investigational (non-licensed experimental) drug with effects on bone metabolism * Contraindication to teriparatide or zoledronic acid * Women of childbearing potential not using highly effective methods of contraception * Pregnancy * Women that are breastfeeding * Age \< 18 years

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Conditions

The condition(s) this trial relates to.

bone fracture osteogenesis imperfecta

As listed by the trial registrant

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

Osteogenesis imperfecta

Contacts and locations

Locations

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZR, United Kingdom

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Bristol Royal Infirmary

    Bristol, NS2 8HW, United Kingdom

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Guy's and St Thomas' Hospital

    London, SE1 9RT, United Kingdom

  • Haywood Community Hospital

    Stoke-on-Trent, ST6 7AG, United Kingdom

  • James Cook University Hospital

    Middlesbrough, PS4 3BW, United Kingdom

  • Leicester Royal Infirmary

    Leicester, LE1 5WW, United Kingdom

  • Llandough University Hospital

    Llandough, CF64 2XX, United Kingdom

  • Manchester Royal Infirmary

    Manchester, M13 9WL, United Kingdom

  • Ninewells Hospital

    Dundee, DD1 9SY, United Kingdom

  • Northern General Hospital

    Sheffield, S5 7AU, United Kingdom

  • Nottingham City Hospital

    Nottingham, NG5 1PD, United Kingdom

  • Nuffield Orthopaedic Centre

    Oxford, OX3 7HE, United Kingdom

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH, United Kingdom

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF, United Kingdom

  • Royal Liverpool Hospital and Aintree Hospital

    Liverpool, L7 8XP, United Kingdom

  • Royal National Orthopaedic Hospital

    Stanmore, HA7 4LP, United Kingdom

  • Royal Victoria Hospital

    Belfast, BT12 6BA, United Kingdom

  • St Vincent's Hospital

    Dublin, 4, Ireland

  • University Hospital Southampton

    Southampton, S016 6YD, United Kingdom

  • Western General Hospital

    Edinburgh, EH4 2XU, United Kingdom

  • Wishaw General Hospital

    Wishaw, ML2 0DP, United Kingdom

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