30th ASBMR 2008
[M365] Zoledronic Acid Prevents Accelerated Bone Loss after Discontinuation of Teriparatide.
Chad Deal, Katherine Tuthill, Audrey Kriegman.. Cleveland Clinic; Novartis Pharmaceuticals Corporation.
Teriparatide (TPTD) is an anabolic agent approved for daily injection over a 2 year period in patients at high risk for fracture. After discontinuation of TPTD, rapid bone loss ensues. Treatment with antiresorptive agents prevents accelerated bone loss and may therefore maintain the increased bone mass following TPTD. Zoledronic acid 5mg (ZOL) is an IV bisphosphonate approved as a once-yearly infusion for the treatment of postmenopausal osteoporosis. In order to test the ability of ZOL to maintain bone mass after treatment with TPTD, we enrolled 35 postmenopausal women in a trial evaluating the effect of ZOL 5 mg given immediately after a 2-year course of TPTD. The primary endpoint was change in bone density (grams/cm2) in the lumbar spine (LS) (L1-4) at 12 months. Secondary endpoints were change in bone density (grams/cm2) at the total hip (TH), femoral neck (FN) and total body (TB); change in serum c-telopeptide type I collagen (CTX) and serum n-propeptide type I collagen (P1NP). So far, 24 patients have completed 12-months of follow-up, and here we report on changes in bone density in these patients.
The study cohort had a mean age of 68.7 +/- 11.4 and a mean T-score at the time of TPTD discontinuation of -2.1 for both LS and TH. Table 1 summarizes the number of patients exhibiting either maintenance/increase or a decrease in BMD at LS, TH, FN and TB.
Table 1. Number of patients (bone density change from baseline to 12 months)
| Bone density | LS | TH | FN | TB |
| Maintained/ increased | 21 | 24 | 22 | 23 |
| Declined | 3 | 0 | 2 | 1 |
Decline = change >-0.03g/cm2
A single infusion of Zoledronic acid 5 mg appears to be a safe and effective therapy to maintain or increase bone mass in patients after TPTD treatment. It preserves, or increases bone mass in the lumbar spine, total hip, femoral neck and total body in 88%, 100%, 92% and 96% of patients, respectively.
C. Deal, Novartis 1, 3, 4.
Novartis Pharmaceuticals
Date: Monday, September 15, 2008
Session Info: Poster: Osteoporosis Treatment (Clinical): Bisphosphonates (11:30 AM-2:30 PM)
Presentation Time: 11:30 AM