Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal.

Combined elemental calcium / vitamin D chewable tablets. Participants took 2 tablets a day, for a daily dose of calcium 1200 mg/vitamin D 800 IU.

The Qualeffo-41 QoL questionnaire was completed by the patient at Baseline and at Month 12. The questionnaire includes 41 questions covering 7 domains (pain, physical function and activities of daily living, physical function and jobs around the house, physical function and mobility, leisure and social activities, general health perception, mental function). Scores on each question range from 1 to 3, 4, or 5. The total score summed over all questions ranges from 41-205 points; the lower the score the higher the quality of life. A negative change score indicates improvement.

A diagnosis of clinical fracture was based on physical examination findings, ie, swelling, tenderness, limited movement, pain.

Body height was measured at Baseline and at the end of the study (Month 12) and the change in height calculated.

Patients were administered a questionnaire at the end of the study in which they were asked which type of therapy, weekly oral or yearly iv, they preferred.

Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.

Total of all reporting groups

Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.

The level of bone activity as measured by P1NP over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study.

Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.

The Qualeffo-41 QoL questionnaire was completed by the patient at Baseline and at Month 12. The questionnaire includes 41 questions covering 7 domains (pain, physical function and activities of daily living, physical function and jobs around the house, physical function and mobility, leisure and social activities, general health perception, mental function). Scores on each question range from 1 to 3, 4, or 5. The total score summed over all questions ranges from 41-205 points; the lower the score the higher the quality of life. A negative change score indicates improvement.

Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.

A diagnosis of clinical fracture was based on physical examination findings, ie, swelling, tenderness, limited movement, pain.

Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.

Body height was measured at Baseline and at the end of the study (Month 12) and the change in height calculated.

Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.

Patients were administered a questionnaire at the end of the study in which they were asked which type of therapy, weekly oral or yearly iv, they preferred.

Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.

The level of bone activity as measured by NTx over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study.

Per Protocol population: All intent-to-treat patients who did not show major deviations from the protocol procedures that may have had an impact on the study outcome.

Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.