Osteogenesis ImperfectaPhase 3NCT00106028

Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children

A Phase 3 study testing risedronate sodium (Actonel) in people with Osteogenesis Imperfecta, run by Warner Chilcott at 20 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 4 to 15 years
Conditions the study is for: Osteogenesis Imperfecta
What is being tested?: risedronate sodium (Actonel)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 143 participants
Where: 20 sitesin 13 countries
Study dates: Nov 2004to Mar 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 to 15 years
All sexes
No healthy volunteers
Child

Who may be able to join

OI diagnosis
increased risk of fracture: either has a history of at least 1 radiographically confirmed, non-traumatic or low impact fracture plus low bone mineral density (BMD) or has very low BMD with or without a history of fractures.

Who cannot join

Any bisphosphonate use within one year of enrollment

Trial locations and contacts

20 sites in 13 countries.

Country

City, postcode or hospital

20 sites in 13 countries

United States5 sites

Wright State University BioMedical Imaging Laboratory and Miami Valley Hospital
Dayton, Ohio, 45409
Miami Children's Hospital
Miami, Florida, 33155
Hospital for Special Surgery
New York, New York, 10021
University of Nebraska Medical Center, Children's Hospital
Omaha, Nebraska, 68114
Oregon Health & Science University
Portland, Oregon, 97239

Other trials in United States

United Kingdom3 sites

Bristol Royal Hospital for Children,
Bristol
Royal Hospital for Sick Children
Glasgow, Glasgow, G3 8SJ
Sheffield Children's Hospital
Sheffield, Sheffield, S210 2TH

Other trials in United Kingdom

Australia2 sites

Princess Margaret Hospital for Children
Perth
The Children's Hospital at Westmead
Westmead, New South Wales

Other trials in Australia

Belgium1 site

Cliniques Universitaires Saint Luc
Brussels

Other trials in Belgium

Chile1 site

Pontificia Universidad Catolica de Chile
Santiago

Other trials in Chile

Czechia1 site

Osteocentrum, II. Interní klinika, Fakultní nemocnice Plzeň-Bory
Pilsen

Other trials in Czechia

Finland1 site

Hospital for Children and Adolescents
Helsinki

Other trials in Finland

Germany1 site

Klinikum und Poliklinik für Kinderheilkunde der Universität zu Köln
Cologne

Other trials in Germany

Hungary1 site

2nd Department of Pediatrics, Semmelwies University, Faculty of Medicine
Budapest

Other trials in Hungary

Italy1 site

Rheumatologic Rehabilitation Unit of the University of Verona
Valeggio sul Mincio

Other trials in Italy

Poland1 site

Zaklad Biochemii i Medycyny Doswiadczalnej (Biochemisty Dept, Institute "Monument-Children Health Centre"
Warzawa-Międzylesie

Other trials in Poland

South Africa1 site

Little Company of Mary Hospital
Pretoria, Gauteng

Other trials in South Africa

Spain1 site

Hospital Sant Joan de Deu
Barcelona

Other trials in Spain

About this study

Children with Osteogenesis Imperfecta (OI) have bone pain, low bone mass and fractures. There are no approved drugs for the treatment of OI in children, even though some intravenous (IV) bisphosphonates are used off-label in some countries. In a single dose, pharmacokinetic study, data showed that risedronate was well tolerated in 28 children with OI. This three year study will test the safety and efficacy of risedronate in the treatment of children with OI. For the first year, patients will be randomized to the risedronate and placebo groups in a 2:1 ratio. For the second and third years of the study, all patients will receive risedronate.

Conditions: Osteogenesis Imperfecta
Being tested: risedronate sodium (Actonel), Placebo
Keywords: Primary disease: Osteogenesis Imperfecta
Medical subject headings: Osteogenesis Imperfecta

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

risedronate sodium (Actonel)Drug
risedronate tablet once a day for one year followed by risedronate once a day for two years
PlaceboDrug
placebo tablet once a day for one year followed by risedronate once a day for two years

Study groups in NCT00106028
Study group	Role	What they receive
Placebo Daily	Placebo comparator	placebo tablet, once a day for one year then for two years open label risedronate Receives: Drug: Placebo
Risedronate Daily	Experimental	risedronate tablet, once a day for one year then for two years open label risedronate once a day Receives: Drug: risedronate sodium (Actonel)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 12, ITT Population
Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader. Duplicate scans obtained at screening and Month 12.
Measured: Baseline and Month 12

Secondary outcomes (43)

Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 24, ITT Population
Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader.
Measured: Baseline and Month 24
Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 36, ITT Population
Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader.
Measured: Baseline and Month 36
Percent Change From Baseline in Total Body BMD at Month 12, ITT Population
Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.
Measured: Baseline and Month 12
Percent Change From Baseline in Total Body BMD at Month 24, ITT Population
Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.
Measured: Baseline and Month 24
Percent Change From Baseline in Total Body BMD at Month 36, ITT Population
Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.
Measured: Baseline and Month 36
Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 12, ITT Population
Measured: Baseline and Month 12
Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 24, ITT Population
Measured: Baseline and Month 24
Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 36, ITT Population
Measured: Baseline and Month 36
Percent Change From Baseline in Total Body BMC at Month 12, ITT Population
Measured: Baseline and Month 12
Percent Change From Baseline in Total Body BMC at Month 24, ITT Population
Measured: Baseline and Month 24
Percent Change From Baseline in Total Body BMC at Month 36, ITT Population
Measured: Baseline and Month 36
Lumbar Spine Z-score - Percent Change From Baseline to Month 12, ITT Population
Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values".
Measured: Baseline and Month 12
Lumbar Spine Z-score - Percent Change From Baseline to Month 24, ITT Population
Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values".
Measured: Baseline and Month 24
Lumbar Spine Z-score - Percent Change From Baseline to Month 36, ITT Population
Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values".
Measured: Baseline and Month 36
Total Body Z-score- Percent Change From Baseline to Month 12, ITT Population
Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values".
Measured: Baseline and Month 12
Total Body Z-score- Percent Change From Baseline to Month 24, ITT Population
Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values".
Measured: Baseline and Month 24
Total Body Z-score- Percent Change From Baseline to Month 36, ITT Population
Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values".
Measured: Baseline and Month 36
Percent Change From Baseline in Lumbar Spine Bone Area at Month 12, ITT Population
Measured by DXA.
Measured: Baseline and Month 12
Percent Change From Baseline in Lumbar Spine Bone Area at Month 24, ITT Population
Measured by DXA.
Measured: Baseline and Month 24
Percent Change From Baseline in Lumbar Spine Bone Area at Month 36, ITT Population
Measured by DXA.
Measured: Baseline and Month 36
Percent Change From Baseline in Total Body Bone Area Month 12, ITT Population
Measured: Baseline and Month 12
Percent Change From Baseline in Total Body Bone Area Month 24, ITT Population
Measured: Baseline and Month 24
Percent Change From Baseline in Total Body Bone Area Month 36, ITT Population
Measured: Baseline and Month 36
New Morphometric Vertebral Fracture at Month 12, ITT Population
Morphometric Vertebral Fracture measured by semi-quantitative (SQ) analysis of x-rays using the Genant scoring system at endpoint. (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). New fracture = SQ score is 0 at baseline and >0 at the specified end visit.
Measured: Baseline and Month 12
New Morphometric Vertebral Fracture at Month 36, ITT Population
Morphometric Vertebral Fracture measured by SQ analysis of x-rays using the Genant scoring system. (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). New fracture = SQ score is 0 at baseline and >0 at the specified end visit.
Measured: Baseline and Month 36
Categorization by Number of New Morphometric Vertebral Fracture at Month 12, ITT
Patients with 1 or more New Morphometric Vertebral Fracture as measured by SQ analysis of x-rays using the Genant scoring system (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). Incidence = SQ score is 0 at baseline and >0 at post-baseline.
Measured: Baseline and Month 12
Categorization by Number of New Morphometric Vertebral Fracture at Month 36, ITT
Patients with 1 or more New Morphometric Vertebral Fracture as measured by SQ analysis of x-rays using the Genant scoring system (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). Incidence = SQ score is 0 at baseline and >0 at post-baseline.
Measured: Baseline and Month 36
Incidence New Vertebral Fractures by SQ (Semi-Quantitative) Score, Patients Aged 4-9 Years, Month 12, ITT Population
Patients aged 4-9 years with new morphometric vertebral fractures as measured by SQ analysis of x-rays using the Genant scoring system at Month 12 +/- 14 days. (Ref: Genant 1993). SQ Score mild - 0/no fracture to Grade 1, Moderate to Severe - change from 0/no fracture to Grade 2-3.
Measured: Month 12
Incidence New Vertebral Fractures by SQ Score, Patients Aged 10-15 Years, Month 12, ITT Population
Patients aged 10-15 years with new morphometric vertebral fractures as measured by SQ analysis of x-rays using the Genant scoring system at Month 12 +/- 14 days. (Ref: Genant 1993). SQ Score mild - 0/no fracture to Grade 1, Moderate to Severe - change from 0/no fracture to Grade 2-3.
Measured: Month 12
Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population
Long bones include radius, ulna, humerus, tibia, fibula, femur, upper limb and lower limb fracture.
Measured: Time to First Event (days) up to 12 Months
Number of Clinical Fractures, Month 12, ITT Population
Long bones include radius, ulna, humerus, tibia, fibula, femur, upper limb and lower limb fracture.
Measured: 12 Months
Serum BAP - Percent Change From Baseline to Month 12, ITT Population
Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.
Measured: Baseline and 12 Months
Serum BAP - Percent Change From Baseline to Month 24, ITT Population
Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.
Measured: Baseline and 24 Months
Serum BAP - Percent Change From Baseline to Month 36, ITT Population
Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.
Measured: Baseline and 36 Months
Urine NTX/Cr - Percent Change From Baseline at Month 12, ITT Population
Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.
Measured: Baseline and Endpoint / Month 12
Urine NTX/Cr - Percent Change From Baseline at Month 24, ITT Population
Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.
Measured: Baseline and Month 24
Urine NTX/Cr - Percent Change From Baseline at Month 36, ITT Population
Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.
Measured: Baseline and Month 36
Wong-Baker FACES Pain Rating Scale - Change From Baseline to Month 12, ITT Population
Wong-Baker FACES Pain Rating Scale (pain assessment scale using facial expressions, translated into a range from 0= no pain [smiling face] to 10= worst pain possible [distorted face with tears]; negative values indicate decrease in pain). Reference: Wong DL et al.
Measured: Baseline and Month 12
Bone Age (Years), Change From Baseline to Month 12, ITT Population
Bone Age determined by visual assessment of hand / wrist radiographs.
Measured: Baseline and Month 12
Bone Age (Years), Change From Baseline to Month 24, ITT Population
Bone Age determined by visual assessment of hand / wrist radiographs.
Measured: Baseline and Month 24
Bone Age (Years), Change From Baseline to Month 36, ITT Population
Bone Age determined by visual assessment of hand / wrist radiographs.
Measured: Baseline and Month 36
Annualized Growth Velocity - Change From Baseline to Month 12, ITT Population
Annualized Growth Velocity [= bone age change from baseline x (365.25/time in days between baseline and the bone age measurement)]
Measured: Baseline and Month 12
Annualized Growth Velocity - Change From Baseline to Month 36, ITT Population
Annualized Growth Velocity [= bone age change from baseline x (365.25/time in days between baseline and the bone age measurement)]
Measured: Baseline and Month 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2004Mar 2010

First posted21 Mar 2005 (estimated)
Study startNov 2004
Primary completionApr 2008
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Osteogenesis ImperfectaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 143 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00106028
Sponsor's protocol ID: 2003100
Other IDs: HMR4003I/3001
Status last verified: Apr 2013
First submitted: 18 Mar 2005
Last updated: 22 Apr 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Bishop N, Adami S, Ahmed SF, Anton J, Arundel P, Burren CP, Devogelaer JP, Hangartner T, Hosszu E, Lane JM, Lorenc R, Makitie O, Munns CF, Paredes A, Pavlov H, Plotkin H, Raggio CL, Reyes ML, Schoenau E, Semler O, Sillence DO, Steiner RD. Risedronate in children with osteogenesis imperfecta: a randomised, double-blind, placebo-controlled trial. Lancet. 2013 Oct 26;382(9902):1424-32. doi: 10.1016/S0140-6736(13)61091-0. Epub 2013 Aug 6.
PubMed 23927913

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN)
Osteogenesis Imperfecta (OI)
Active, not recruitingObservational study
Cardiopulmonary Outcomes in Osteogenesis Imperfecta: BBD7708
Osteogenesis Imperfecta
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
Active, not recruitingPhase 3
Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta
Osteogenesis Imperfecta
Active, not recruitingPhase 2/3
Setrusumab vs Placebo for Osteogenesis Imperfecta
Osteogenesis Imperfecta

All Osteogenesis Imperfecta trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children
ClinicalTrials.gov ID: NCT00106028
Acronym / sponsor ID: 2003100
Conditions: Osteogenesis Imperfecta
Keywords: Primary disease: Osteogenesis Imperfecta
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 143 participants (actual)
Lead sponsor: Warner ChilcottIndustry (pharma, biotech, devices)
Study start: Nov 2004
Primary completion: Apr 2008 (actual)
Study completion: Mar 2010 (actual)
First posted: 21 Mar 2005 (estimated)
Results: Posted 28 Jun 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo Daily	Placebo comparator	Drug: Placeboplacebo tablet, once a day for one year then for two years open label risedronate
Risedronate Daily	Experimental	Drug: risedronate sodium (Actonel)risedronate tablet, once a day for one year then for two years open label risedronate once a day

Who may qualify

Ages: 4 to 15 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

OI diagnosis
increased risk of fracture: either has a history of at least 1 radiographically confirmed, non-traumatic or low impact fracture plus low bone mineral density (BMD) or has very low BMD with or without a history of fractures.

Key exclusion criteria (1 listed)

Any bisphosphonate use within one year of enrollment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
risedronate sodium (Actonel)risedronate tablet once a day for one year followed by risedronate once a day for two years	Drug	Risedronate Daily
Placeboplacebo tablet once a day for one year followed by risedronate once a day for two years	Drug	Placebo Daily

Primary outcome

Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 12, ITT Population
Time frame: Baseline and Month 12
Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader. Duplicate scans obtained at screening and Month 12.

43 secondary outcomes

Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 24, ITT Population
Time frame: Baseline and Month 24
Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 36, ITT Population
Time frame: Baseline and Month 36
Percent Change From Baseline in Total Body BMD at Month 12, ITT Population
Time frame: Baseline and Month 12
Percent Change From Baseline in Total Body BMD at Month 24, ITT Population
Time frame: Baseline and Month 24
Percent Change From Baseline in Total Body BMD at Month 36, ITT Population
Time frame: Baseline and Month 36
Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 12, ITT Population
Time frame: Baseline and Month 12
Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 24, ITT Population
Time frame: Baseline and Month 24
Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 36, ITT Population
Time frame: Baseline and Month 36
Percent Change From Baseline in Total Body BMC at Month 12, ITT Population
Time frame: Baseline and Month 12
Percent Change From Baseline in Total Body BMC at Month 24, ITT Population
Time frame: Baseline and Month 24
Percent Change From Baseline in Total Body BMC at Month 36, ITT Population
Time frame: Baseline and Month 36
Lumbar Spine Z-score - Percent Change From Baseline to Month 12, ITT Population
Time frame: Baseline and Month 12
Lumbar Spine Z-score - Percent Change From Baseline to Month 24, ITT Population
Time frame: Baseline and Month 24
Lumbar Spine Z-score - Percent Change From Baseline to Month 36, ITT Population
Time frame: Baseline and Month 36
Total Body Z-score- Percent Change From Baseline to Month 12, ITT Population
Time frame: Baseline and Month 12
Total Body Z-score- Percent Change From Baseline to Month 24, ITT Population
Time frame: Baseline and Month 24
Total Body Z-score- Percent Change From Baseline to Month 36, ITT Population
Time frame: Baseline and Month 36
Percent Change From Baseline in Lumbar Spine Bone Area at Month 12, ITT Population
Time frame: Baseline and Month 12
Percent Change From Baseline in Lumbar Spine Bone Area at Month 24, ITT Population
Time frame: Baseline and Month 24
Percent Change From Baseline in Lumbar Spine Bone Area at Month 36, ITT Population
Time frame: Baseline and Month 36
Percent Change From Baseline in Total Body Bone Area Month 12, ITT Population
Time frame: Baseline and Month 12
Percent Change From Baseline in Total Body Bone Area Month 24, ITT Population
Time frame: Baseline and Month 24
Percent Change From Baseline in Total Body Bone Area Month 36, ITT Population
Time frame: Baseline and Month 36
New Morphometric Vertebral Fracture at Month 12, ITT Population
Time frame: Baseline and Month 12
New Morphometric Vertebral Fracture at Month 36, ITT Population
Time frame: Baseline and Month 36
Categorization by Number of New Morphometric Vertebral Fracture at Month 12, ITT
Time frame: Baseline and Month 12
Categorization by Number of New Morphometric Vertebral Fracture at Month 36, ITT
Time frame: Baseline and Month 36
Incidence New Vertebral Fractures by SQ (Semi-Quantitative) Score, Patients Aged 4-9 Years, Month 12, ITT Population
Time frame: Month 12
Incidence New Vertebral Fractures by SQ Score, Patients Aged 10-15 Years, Month 12, ITT Population
Time frame: Month 12
Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population
Time frame: Time to First Event (days) up to 12 Months
Number of Clinical Fractures, Month 12, ITT Population
Time frame: 12 Months
Serum BAP - Percent Change From Baseline to Month 12, ITT Population
Time frame: Baseline and 12 Months
Serum BAP - Percent Change From Baseline to Month 24, ITT Population
Time frame: Baseline and 24 Months
Serum BAP - Percent Change From Baseline to Month 36, ITT Population
Time frame: Baseline and 36 Months
Urine NTX/Cr - Percent Change From Baseline at Month 12, ITT Population
Time frame: Baseline and Endpoint / Month 12
Urine NTX/Cr - Percent Change From Baseline at Month 24, ITT Population
Time frame: Baseline and Month 24
Urine NTX/Cr - Percent Change From Baseline at Month 36, ITT Population
Time frame: Baseline and Month 36
Wong-Baker FACES Pain Rating Scale - Change From Baseline to Month 12, ITT Population
Time frame: Baseline and Month 12
Bone Age (Years), Change From Baseline to Month 12, ITT Population
Time frame: Baseline and Month 12
Bone Age (Years), Change From Baseline to Month 24, ITT Population
Time frame: Baseline and Month 24

Results and safety

Results posted to the registry on 28 Jun 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Daily	49	43
Risedronate Daily	94	82

Primary outcome: Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 12, ITT Population

Time frame: Baseline and Month 12. Least squares mean (95% Confidence Interval). Unit: Percent Change

Measure	Placebo Daily n = 49	Risedronate Daily n = 94
Value	7.592 (5.106 to 10.078)	16.159 (14.295 to 18.024)

Placebo Daily vs Risedronate Daily: Mean Difference (Net): 8.567 (95% CI 5.590 to 11.545), p <0.0001, ANCOVA

Population analysed: ITT Population

43 secondary outcomes are reported in the full results.

Adverse events

Time frame: 36 months: One year double-blind treatment, 2 years open-label risedronate treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Daily	8 of 49 (16.3%)	47 of 49 (95.9%)	Not reported
Risedronate Daily	11 of 94 (11.7%)	86 of 94 (91.5%)	Not reported
Years 2 & 3 Placebo-Risedronate	13 of 49 (26.5%)	46 of 49 (93.9%)	Not reported
Years 2 & 3 Risedronate	16 of 87 (18.4%)	79 of 87 (90.8%)	Not reported

Limitations and caveats (from the sponsor): The clinical meaningfulness of new fractures in the thoracic spine scored as Genant Grade I is unclear, thus the morphometric vertebral fracture data are evaluated further.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23927913Bishop N, Adami S, Ahmed SF, Anton J, Arundel P, Burren CP, Devogelaer JP, Hangartner T, Hosszu E, Lane JM, Lorenc R, Makitie O, Munns CF, Paredes A, Pavlov H, Plotkin H, Raggio CL, Reyes ML, Schoenau E, Semler O, Sillence DO, Steiner RD. Risedronate in children with osteogenesis imperfecta: a randomised, double-blind, placebo-controlled trial. Lancet. 2013 Oct 26;382(9902):1424-32. doi: 10.1016/S0140-6736(13)61091-0. Epub 2013 Aug 6.

Related trials for Osteogenesis Imperfecta

RecruitingPhase 2
Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN)
Osteogenesis Imperfecta (OI)
Active, not recruitingObservational study
Cardiopulmonary Outcomes in Osteogenesis Imperfecta: BBD7708
Osteogenesis Imperfecta
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
Active, not recruitingPhase 3
Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta
Osteogenesis Imperfecta
Active, not recruitingPhase 2/3
Setrusumab vs Placebo for Osteogenesis Imperfecta
Osteogenesis Imperfecta

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dietrich H Wenderoth, MD study director

Procter and Gamble

20 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing risedronate sodium (Actonel) in people with Osteogenesis Imperfecta, run by Warner Chilcott at 20 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, United Kingdom, Australia, Belgium, Chile and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 12, ITT Population (time frame: Baseline and Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00106028, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2013.