A randomized, double-blind, placebo-controlled study to evaluate the persistence of the effect of oral monthly ibandronate on bone resorption in postmenopausal women with osteoporosis - Oral Monthly Ibandronate In Postmenopausal Women with Osteoporosis

• Register: EUCTR
• Last refreshed on: 15 July 2013
• Main ID: EUCTR2004-001750-81-GB
• Date of registration: 17/02/2005
• Prospective Registration: No
• Primary sponsor: Merck Sharp & Dohme Limited
• Public title: A randomized, double-blind, placebo-controlled study to evaluate the persistence of the effect of oral monthly ibandronate on bone resorption in postmenopausal women with osteoporosis - Oral Monthly Ibandronate In Postmenopausal Women with Osteoporosis
• Scientific title: A randomized, double-blind, placebo-controlled study to evaluate the persistence of the effect of oral monthly ibandronate on bone resorption in postmenopausal women with osteoporosis - Oral Monthly Ibandronate In Postmenopausal Women with Osteoporosis
• Date of first enrolment: 13/01/2005
• Target sample size: 180
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001750-81
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Germany, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
• Community-dwelling, ambulatory woman, > 50 years of age and postmenopausal for at least 3 years, with osteoporosis
• In a state of general good health
• Understands the procedures of the study, has been informed of alternative treatments for osteoporosis, and voluntarily agrees to participate in the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
•The patient is mentally or legally incapacitated, or otherwise unable to give informed consent.
•The patient is a pregnant or lactating woman or a woman of childbearing potential.
•The patient has a history of hypersensitivity to any component of ibandronate tablets or the patient has any of the rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. (Ibandronate tablets contain lactose and should not be administered to patients with these conditions.)
•The patient has a history of any illness or has significant abnormalities which might either pose an unacceptable risk to the patient from participation in this study or complicate the interpretation of study data.
•The patient has an abnormality of the esophagus which delays esophageal emptying such as stricture or achalasia.
•The patient is unable to stand or sit upright for at least 60 minutes once a month.
•The patient is a current user of any illicit drugs or has a history of drug or alcohol abuse within the past five years.
•The patient has any of the following: hypocalcemia; any severe malabsorption syndrome; moderate or severe hypertension which is uncontrolled; new onset angina or myocardial infarction; evidence for impaired renal function; organ transplantation; or other significant end organ diseases (genitourinary, cardiovascular, endocrine, hepatic, psychiatric, renal, hematologic, or pulmonary) which may pose an added risk to the patient or impair the patient's ability to complete the trial.
•The patient has a history of or evidence for metabolic bone disease (other than postmenopausal bone loss).
•The patient has experienced a clinical fracture in the past year.
•The patient has a history of cancer.
•The patient is receiving or has received treatment prior to randomization which might influence bone turnover, including:
-intravenous or oral bisphosphonate.
-parathyroid hormone.
-within the past 6 months: estrogen, any estrogen analogue (e.g., raloxifene, tamoxifen), tibolone, aromatase inhibitor or anabolic steroid. Topical (vaginal) estrogen cream (<2 g) used up to two times weekly is acceptable.
-thyroid hormone, unless on a stable dose for at least six weeks before randomization with serum TSH within the normal range and no plans to alter the dose during the course of the study.
-fluoride at a dose greater than 1 mg/day for more than one month at any time.
-strontium ranelate.
-glucocorticoid treatment for more than one month with > 5 mg of oral prednisone (or the equivalent) per day within six months prior to randomization.
-immunosuppressant treatment (e.g., cyclosporine, azathioprine) within the previous year.
•Vitamin A in excess of 10,000 IU per day or Vitamin D in excess of 5000 IU per day, calcitonin, phenytoin, heparin, or lithium.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Osteoporosis in postmenopausal women.
MedDRA version: 7.0 Level: LLT Classification code 10031282

Intervention(s)

Trade Name: Bondronat 50 mg Film-coated Tablets
Product Name: Bondronat
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ibandronic acid
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Calcichew-D3 Chewable Tablets
Product Name: Calcichew-D3 Chewable Tablets
Pharmaceutical Form: Chewable tablet
INN or Proposed INN: Calcium 500 mg/colecalciferol 5 micrograms
Concentration unit: g gram(s)
Concentration type: range
Concentration number: 1.25g calcium crb-200 IU colecalcif

Primary Outcome(s)

Secondary Objective: Secondary objectives :
In postmenopausal women with osteoporosis:
• Persistence of effect of oral monthly ibandronate, 100 mg and 150 mg, on urinary NTx/Cr during the third month of treatment
• Effect of oral monthly ibandronate, 100 mg and 150 mg, on the proportion of patients with markers of bone resorption above the pre-specified reference levels
• Persistence of the effect of oral monthly ibandronate, 100 mg and 150 mg, on percent change from baseline in the biochemical markers of bone resorption during the first and second month
• Safety and tolerability of oral monthly ibandronate, 100 mg and 150 mg, and placebo

Main Objective: In postmenopausal women with osteoporosis, to evaluate and compare with placebo the persistence of the effect of oral monthly ibandronate, 100 mg and 150 mg, on percent change from baseline in the biochemical marker of bone resorption, serum carboxyterminal crosslinked telopeptide of Type I collagen (CTx1), during the third month treatment (four weeks post dose compared to one week post dose).

Primary end point(s): Change from Week 9 (one week post dose) at Week 12 (four weeks post dose) in serum CTxI log-transformed fraction from baseline.

Secondary ID(s)

908

2004-001750-81-DE