A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE

• Conditions: Osteogenesis Imperfecta

• Registration Number: EUCTR2004-000485-13-HU
• Lead Sponsor: Procter & Gamble Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

To be enrolled in this study, a child must meet the following:
a) diagnosed with OI as based on a modified classification scale7,8 (Appendix 1)
b) aged 4 through 15 years (= 4 to < 16), inclusive
c) have an increased risk of fractures as defined by:
• a history of at least 1 radiographically confirmed, non-traumatic or low impact
fracture, plus low BMD (Z-score = -1 at either total body or lumbar spine sites);
or
• very low BMD (Z-score = -2.0 at either total body or lumbar spine sites) with or
without a history of fractures
d) have at least 2 evaluable lumbar spine vertebral bodies (L1-L4), namely without fracture or degenerative disease
e) if female, post-menarche and sexually active, must be willing to agree to use a reliable contraceptive measure for the duration of the study. Acceptable forms of contraception include oral, injected or implanted contraceptives, or intrauterine devices.
f) if female and post-menarche, must have a negative serum and urine pregnancy test at Screening
g) able and willing to participate in the study as evidenced by a parent/legal guardian signing a valid written informed consent and the patient signing an assent (if appropriate).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a) body weight < 10 kg
b) history of cancer within the past 5 years
c) untreated rickets within 1 year prior to enrollment
d) history of clinically significant organic or psychiatric disease or findings on physical
examination, which in the opinion of the Investigator, would prevent the patient from
completing the study
e) documented history of an abnormal or allergic reaction to bisphosphonates
f) abuse of alcohol
g) abuse of prescription or illicit drugs
h) history of using any of the following medications, regardless of dose, for at least
1 month, within 3 months of enrollment:
• anabolic agents
• estrogen (except contraceptives)
• progestogens (except contraceptives)
• calcitriol, calcidiol, or alfacalcidol
• calcitonin
• fluoride (except dental health products)
• glucocorticoids (does not include inhaled glucocorticoids)
• growth hormones
• parathyroid hormone (PTH)
• strontium
i) history of using any bisphosphonates within 1 year of enrollment, except for a single dose of oral bisphosphonate, such as risedronate or alendronate
j) osteoporosis, secondary to diseases other than OI or drug therapies
k) clinically significant abnormal laboratory finding at Screening, as follows:
• liver function test (LFT), either AST or ALT > 2 x ULN
• thyroid stimulating hormone (TSH) and PTH outside of the normal reference range
Note: An iPTH level below the lower limit of the normal range may be associated
with calcium supplementation. Therefore, the Investigator and the Medical Monitor
will review the patient's personal data and medical history to confirm or refute that
the low iPTH level is associated with high calcium supplementation
• serum 25(OH) vitamin D < 20 nmol/L (8 ng/mL)
• serum creatinine > 106 µmol/L (1.2 mg/dL)
l) current use of anticonvulsant medication
m) current use of anticoagulant medication
n) participation in another clinical trial within 3 months of enrollment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified