The TOMIBA studyTreatment of Osteoporotic Men With Intravenous Ibandronate An open-label, single-center, prospective Phase III study - TOMIBA

• Conditions: Osteoporosis in Men

• Registration Number: EUCTR2006-006692-20-AT
• Lead Sponsor: St. Vincent Hospital, Medical Department II

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

a)The patient is a man aged from 20 to 85 years.

b)The patient has a T-score of = -2 at the femoral neck and a T-score of = -1 at the lumbar spine
or
has a T-score of = -1 at the femoral neck and at least one moderate vertebral deformity (meeting the Genant criteria) or at least one non-vertebral low trauma fracture , .

c)The patient’s lumbar spine is suitable for dual-energy x-ray absorptiometry (DXA)
At least 2 vertebrae between L1 and L4 are measurable. (i.e. not fractured or filled with cement etc.)
NOTE: Fractured vertebrae must be excluded from measurement and therefore do not account for the patient’s lumbar spine BMD.

d)The patient’s 25-hydroxyvitamin D level is = 10 ng/ml.
Note: Rescreening is allowed in case of vitamin D deficiency; if rescreening takes places earlier than 6 months after the baseline visit DXA, X-ray and ECG must not be repeated); otherwise the entire screening procedure must be completed.

e)The patient does not suffer from any metabolic bone disease OTHER THAN primary osteoporosis/osteopenia OR osteoporosis/osteopenia associated with low testosterone levels.

f)The patient has sufficiently been informed about the study procedures including bone biopsy. He is able and willing to give his written consent.

g)The patient agrees not to use any antiosteoporotic medications except those provided by this study. (Calcium and vitamin D supplements can in case of product intolerance be changed to equivalent or similar preparations.)

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

a)The patient has received or receives any of the following medications: (a) oral bisphosphonates within the last 6 months, (b) i.v. bisphosphonates at any time, (c) anabolic steroids or glucocorticoids (= 5 mg prednisone equivalent for more than 2 weeks within the last 6 months, (d) fluorides at any time (except fluorides for dental prophylaxis) , (e) strontiumranelate at any time, (f) PTH at any time, (g) current use of antiepileptic substances or thyroid hormones (i) recently initiated androgen replacement therapy
(Note: Patients on stable androgen levels under ongoing androgen replacement therapy for at least 6 months will be allowed)

b)The patient has taken either calcitonin and/or SERMs within the last 6 months.

c)Both hips of the patient are unsuitable for DXA. (e.g. hip replacements)

d)The patient suffers from thyroid hypo- or hyperfunction .His TSH is beyond the given range of 0,27 – 4,20 µU/ml.

e)The patient has a history of prior malignancy within the last five years;
(exception basal cell carcinoma)

Study & Design

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