Two-Year Changes in Bone Mineral Density and T Scores in Patients Treated at a Pharmacist-Run Teriparatide Clinic
This viewpoint offers commentary on important clinical research in the area of pharmacy.
Stroup JS, Rivers SM, Abu-Baker AM, et al
Pharmacotherapy. 2007;27:779-788
Study Summary
Teriparatide (Forteo, made by Eli Lilly) is the first anabolic agent approved for the treatment of osteoporosis, but its clinical use can be challenging for various reasons, including its parenteral administration and the potential for adverse events. A group of pharmacists established a clinic at a private endocrinology practice to oversee the management of patients with osteoporosis who were given teriparatide. After a pharmacist counseling and training session, patients were able to self-administer subcutaneous teriparatide 20 micrograms/day for 2 years.
The primary outcome measures for this prospective, observational study were bone mineral density (BMD) and T scores for the total hip, spine, and wrist after 1 and 2 years of therapy, compared with baseline scores.
Patients' BMD for the hip increased by 3.5% at 1 year and by 3.9% at 2 years. Moreover, BMD for the spine significantly increased by 7.2% at 1 year and 10.9% at 2 years. However, BMD for the wrist decreased by 0.75% at 1 year and by 2.4% at 2 years, but the change was only significant at 2 years (P = .011). Overall, at both 1 and 2 years, T scores for the total hip and spine significantly improved from baseline (P = .019), while T scores for the wrist significantly declined after 2 years of therapy (P < .003). Within the 2-year study period, no new fractures were documented in any of the patients.
Viewpoint
Teriparatide carries a black-box warning from the US Food and Drug Administration, warning that treatment should be avoided in patients with an increased baseline risk for osteosarcoma (eg, those with Paget's disease, elevated alkaline phosphatase levels, or previous radiation therapy involving the skeleton); furthermore, treatment should not exceed 2 years. Patients who qualified to receive teriparatide in this study had demonstrated an intolerance to antiresorptive therapy (eg, alendronate, risedronate, ibandronate) or a lack of efficacy with antiresorptive therapy.
Given the warnings and administration techniques associated with teriparatide, along with its high cost, the need arose for a pharmacist-run clinic to screen potential candidates, teach drug administration, and help obtain drug insurance coverage. Patients received an initial 1-hour counseling session with a pharmacist, with a follow-up call from the pharmacist 1 week later and a 1-month review at the clinic.
This study provides an example of how pharmacists can help manage patients who are taking medications that have unusual characteristics, such as those with difficult administration techniques or the potential for adverse events. The study's results demonstrated that teriparatide produces BMD increases in the hip and spine and may reduce the risk for bone fracture in patients with osteoporosis. Unfortunately, there was a noted decrease in BMD in the wrist. This model of establishing a pharmacist-run clinic in a private medical practice potentially could be used to develop similar clinics in other specialized practice settings.
Abstract