The purposes of this study are to study the effect of long-term treatment with monthly oral ibandronate 100 mg and 150 mg, given as a single tablet, on the lumbar spine and hip BMD and bone turnover, and to assess the overall long-term tolerability and safety of the treatment regimens.

Condition	Treatment or Intervention	Phase
Osteoporosis	Drug: BM 21.0955 Na•H2O Oral (USAN:ibandronate sodium, INN:iband acid)	Phase III

Ages Eligible for Study:  57 Years   -   82 Years,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria:

• Patients who completed study BM16549 (2-year treatment oral ibandronate, 2.5 mg, 100 mg or 150 mg, double-blind) and who had complied with the monthly regimen for 75% or more
• Patients who are ambulatory at the beginning of the trial. It must not be anticipated that the patient becomes hospitalized, immobilized, or bedridden during the course of the trial
• Patients who, in the opinion of the investigator, are able and willing to comply with the protocol for its duration
• Patients who have provided written informed consent to participate in the study

Exclusion Criteria:

• Severe renal failure (1 calculated GFR less than 30 ml/min.)
• Malignant disease diagnosed within the previous 12 years (except successfully resected basal cell cancer)
• Breast cancer diagnosed within the previous 22 years
• Disease/disorder known to influence bone metabolism: Chronic gastrointestinal or liver disease, chronic alcoholism, severe malabsorption syndrome, primary hyperparathyroidism (patients with surgically treated hyperparathyroidism with documented normal serum calcium and PTH will be eligible for enrollment), Paget's disease of bone, histologically documented osteomalacia, or documented active thyroid disease without treatment
• Administration of any investigational drug other than ibandronate within 30 days preceding the first dose of the study drug
• Treatment with fluoride for osteoporosis (dose greater than 10 mg/day) within the last 12 months, or for more than 2 years (total duration)
• Treatment with PTH or similar agent for osteoporosis within the last 2 years
• Treatment with any bisphosphonate other than oral ibandronate since inclusion in BM16549
• Treatment with other drugs affecting bone metabolism within the last 6 months · Chronic systemic corticosteroid treatment · Systemic hormones (e.g. estrogens, progestins, SERMs, anabolic steroids, active Vit. D analogs/metabolites, calcitonin) · Calcineurin inhibitors (e.g. cyclosporine, tacrolimus) or methotrexate

California
      Loma Linda,  California,  92354,  United States
Colorado
      Lakewood,  Colorado,  80260,  United States
Nebraska
      Omaha,  Nebraska,  68131,  United States
New Jersey
      Livingston,  New Jersey,  07039,  United States
New Mexico
      Albuquerque,  New Mexico,  87106,  United States
Oregon
      Portland,  Oregon,  97220,  United States
      Portland,  Oregon,  97213,  United States
Belgium
      LIEGE,  4020,  Belgium
      MERKSUM,  2170,  Belgium
Brazil
      Sao Paulo,  04026-000,  Brazil
Czech Republic
      Praha,  12800,  Czech Republic
      Plzen,  305 99,  Czech Republic
Denmark
      Aalborg,  9000,  Denmark
      VEJLE,  7100,  Denmark
      BALLERUP,  2750,  Denmark
France
      Lyon,  69003,  France
      Lyon,  69000,  France
      Baillet-en-France,  95560,  France
Germany
      Berlin,  12200,  Germany
      Hannover,  30167,  Germany
Hungary
      Budapest,  1083,  Hungary
      Budapest,  1036,  Hungary
      BALATONFUERED,  8230,  Hungary
      KISKUNHALAS,  6400,  Hungary
      ZALAEGERSZEG,  8900,  Hungary
Italy
      Siena,  53100,  Italy
      Valeggio,  37067,  Italy
Mexico
      Leon,  37000,  Mexico
      Ciudad Obregon,  85100,  Mexico
Norway
      HAUGESUND,  5507,  Norway
      Stavanger,  4010,  Norway
Poland
      Krakow,  31-501,  Poland
      Warszawa,  04-730,  Poland
Spain
      Madrid,  28041,  Spain
      Barcelona,  08907,  Spain
United Kingdom
      Nottingham,  NG2 3HF,  United Kingdom
      Bracknell,  RG12 1HX,  United Kingdom
      Southampton,  SO16 6YD,  United Kingdom

Study ID Numbers:  MA17903
Record last reviewed:  January 2005
Last Updated:  January 18, 2005
Record first received:  April 19, 2004
ClinicalTrials.gov Identifier:  NCT00081653
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08