Study Medication Administration. Patients will self-administer study medication on a daily basis during the Treatment Period. The first self-administration is to occur at the study site under observation. On the days of clinic visits, study medication must be administered in the clinic to accommodate pre-injection and post-injection procedures; study personnel may administer the study medication. Patients will be trained by study personnel during the Pretreatment Period to self-inject study medication with the BA058/Placebo cartridge and pen device. Those patients who are subsequently randomized to teriparatide treatment on Day 1 will be trained in the use of the teriparatide pen on Day 1. If a patient requires assistance with study medication administration, an individual (e.g., a family member) who has been trained by study personnel may provide assistance. Patients will be instructed by the study site to inspect the contents of their study medication device before each injection. If the cartridge or pen contents are not clear and colorless, or if the contents contain particles, the patients will be instructed not to use that cartridge or pen and to contact the study site for further guidance. Injections should be administered in the morning and preferably at the same time each day. All injections are to be given in the periumbilical region, rotating the exact site of injection each day. If it is deemed medically necessary by the investigator for an injection to be administered at a site other than the abdomen, the alternate site of injection is to be recorded and the reason for the change documented in the medical chart. On the first day of study medication administration, the patient should self-inject while in a sitting or lying position at the study site and remain in that position for approximately 5 minutes. The patient is to remain under observation for a minimum of 60 minutes. An orthostatic blood pressure measurement will be taken 60 minutes after the injection. On the days when blood sampling is required after study medication injection, the patient is to Attachment 2, Attachment E-38 remain in the vicinity of the clinic for the blood collections scheduled up to 4 hours post-injection. BA058 80 µg and Placebo will be supplied in cartridges, each containing enough study medication to deliver the required daily dose for 30 days. Patients are to be instructed to change cartridges after 30 days, regardless of how much medication is left in the initial cartridge. Teriparatide will ...
Study Medication Administration. 5.4.1 Alendronate Administration Alendronate must be taken with water only (not mineral water) at least 30 minutes before the first food, beverage or medicinal product (including antacids, calcium supplements and vitamins) of the day. Other beverages (including mineral water), food and some medicinal products are likely to reduce the absorption of alendronate. The following instructions should be followed exactly in order to minimize the risk of esophageal irritation and related adverse reactions. · Alendronate should only be swallowed after getting up for the day with a full glass of water (not less than 200 mL or 7 fl. oz.). · Subjects should only swallow alendronate whole. Subjects should not crush or chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration. · Subjects should not lie down until after their first food of the day. · Subjects should not lie down for at least 30 minutes after taking alendronate. · Alendronate should not be taken at bedtime or before arising for the day. At the Month 3, Month 6, Month 12 and Month 18 visits, the unused alendronate tablets are to be returned to the clinic for counting and the subject will be dispensed additional alendronate. At the Month 24 visit, all unused alendronate tablets are to be returned to the study site.
Study Medication Administration
