Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (4)

Summary of Forteo B Pen Complaints at 8 Weeks
Summary of number of complaints, and common complaints (at least 3% complaint rate), from subjects using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.
8 weeks
Number of Subjects With Forteo B Pen Complaints at 8 Weeks
Number of subjects with complaints after 8 weeks, and common complaints (at least 3% complaint rate), using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.
8 weeks
Summary of Forteo B Pen Complaints at 46 Weeks
Summary of number of complaints, and common complaints (at least 3% complaint rate), from subjects using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.
46 weeks
Number of Subjects With Forteo B Pen Complaints at 46 Weeks
Number of subjects with complaints after 46 weeks, and common complaints (at least 3% complaint rate), using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.
46 weeks

Secondary Outcomes (32)

Summary of Subject Preference Assessments - Overall Preference
4 weeks
Summary of Subject Preference Assessments - Learning to Use the Pen
4 weeks
Summary of Subject Preference Assessments - Attaching a New Needle
4 weeks
Summary of Subject Preference Assessments - Setting the Dose
4 weeks
Summary of Subject Preference Assessments - Injecting a Dose
4 weeks
+27 more secondary outcomes

Interventions

teriparatideDRUG

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.

Also known as: LY333334

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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.
Willing to be trained and use the pen-injector daily to the satisfaction of study site personnel.
Able to read, understand, and respond to self-administered questionnaires.
Without language barrier, cooperative, and expected to return for all follow-up procedures.
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.

You may not qualify if:

Any disease of sufficient severity to preclude treatment with teriparatide or participation in and completion of the study as defined by the investigator.
Having laboratory values, such as elevated serum calcium, precluding teriparatide treatment as defined by the investigator.
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.
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.

Contact the study team to confirm eligibility.