Study of the Experience of Patients With Osteoporosis Using the Forteo B Pen to Self Administer Once Daily Teriparatide Therapy
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: teriparatide
Intervention description: Subcutaneous injection of teriparatide 20 micrograms once daily using the Forteo B Pen. The primary phase of the study is 8 weeks after which time patients may participate in a study extension until the patient completes their maximum duration of teriparatide therapy or the Forteo B Pen becomes commercially available.
Intervention MeSH terms: Teriparatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Healthy volunteers: No

Summary:

      This study is being conducted to collect information from subjects with osteoporosis
      regarding their experience using the Forteo B Pen to self-administer teriparatide in the
      community setting. Information collected during this study will be used to assess the need
      for changes to the Forteo B-Pen User Manual and patient educational tools. Additionally, the
      information generated from patients during this trial will be reviewed to assess the
      acceptability of the Forteo B Pen for commercial launch.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men with primary or hypogonadal osteoporosis or postmenopausal women with osteoporosis
             in the opinion of the investigator. Subjects must be at high risk for fracture in the
             opinion of the investigator.

          2. Willing to be trained and use the pen-injector daily to the satisfaction of study site
             personnel.

          3. Able to read, understand, and respond to self-administered questionnaires.

          4. Without language barrier, cooperative, and expected to return for all follow-up
             procedures.

          5. Have provided written informed consent to participate in this study, according to
             local regulations after being informed of the risks, medications, and procedures to be
             used in the study.

             Exclusion Criteria:

          6. Any disease of sufficient severity to preclude treatment with teriparatide or
             participation in and completion of the study as defined by the investigator.

          7. Having laboratory values, such as elevated serum calcium, precluding teriparatide
             treatment as defined by the investigator.

          8. Subjects who have an increased baseline risk of osteosarcoma, including those with:
             Paget's disease of the bone or unexplained elevations of alkaline phosphatase,
             children and young adults with open epiphyses, and subjects who have received external
             beam or implant radiation therapy involving the skeleton.

          9. History of malignant neoplasms in the 5 years prior to study entry, with the exception
             of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has
             been definitively treated, or history of carcinoma in situ of the cervix or uterus.