NCT01011556已完成2 期
A Phase 2 Study for Transdermal Application of Teriparatide
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 233
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months
研究概览
简要总结
The primary purpose of this study is to help answer the following research questions:
- How teriparatide given using a skin patch (transferred through the skin using the ViaDerm Teriparatide System) compares to teriparatide injected under the skin with a needle (pen injector) affects your bone density (how solid or porous your bones are).
- The safety of the teriparatide skin patch and any side effects that might be associated with it.
详细描述
Teriparatide 20 micrograms (mcg) per day is currently only available as a subcutaneous (SQ) injection and many patients with severe osteoporosis for whom anabolic therapy with teriparatide is appropriate are either unwilling or physically unable to self-inject. The purpose of this Phase 2 study is to identify a transdermal dose or doses that will be comparable to the teriparatide 20 mcg SQ dose from a pharmacodynamic (PD) and safety standpoint for use in future Phase 3 studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ambulatory, postmenopausal women.
- •Centrally confirmed lumbar spine or femoral neck bone mineral density (BMD) T-score of less than or equal to -2.
- •Without language barrier, cooperative, expected to return for all follow-up procedures, and have given informed consent after being informed of the risks, medications, and procedures to be used in the study.
- •Able to use the pen-type injection delivery system and the ViaDerm Teriparatide System satisfactorily in the opinion of the investigator, or with the help of a family member or caregiver.
- •Able to be reached by telephone for follow-up contact between visits
排除标准
- •Abnormal laboratory values for albumin and alkaline phosphatase.
- •Laboratory values outside the ranges defined in the protocol for the following: Serum calcium, intact parathyroid hormone (iPTH), 25 hydroxyvitamin D, and 24-hour urine calcium
- •History of diseases other than postmenopausal osteoporosis that affect bone metabolism, such as Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hypoparathyroidism, hyperparathyroidism, and intestinal malabsorption.
- •History of malignant neoplasms in the 5 years prior to randomization, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to entry into the study may be randomized.
- •Use of a pacemaker.
- •Known chronic dermatological disorder, such as contact dermatitis
- •History of allergy or sensitivity to tapes or adhesives
- •Patients prone to bleeding with coagulopathies, such as hemophilia or thrombocytopenia.
- •Patients who have an increased baseline risk of osteosarcoma, Paget's disease of the bone, or unexplained elevations of alkaline phosphatase; or prior external beam, implant radiation therapy involving the skeleton, or previous primary skeletal malignancy.
- •Major fracture within the past year in the femur, tibia, humerus, or radius (with or without ulna).
- •Treatment with:
- •calcitonins in the 2 months prior to randomization.
- •oral, transdermal/patch, or injectable estrogens, progestins, estrogen analogs, estrogen agonists, estrogen antagonists, selective estrogen receptor modulators, or tibolone in the 3 months prior to randomization; treatment with intravaginal estrogens in doses higher than 0.3 mg of conjugated equine estrogen, or the equivalent, for more than 3 doses per week in the 3 months prior to randomization.
- •androgens or other anabolic steroids in the 6 months prior to randomization.
- •fluorides in the 2 years prior to randomization. (Previous or current use of fluoridated water or topical dental fluoride treatments are permitted.)
- •oral bisphosphonates for more than 2 consecutive months in the 6 months prior to randomization; treatment with intravenous bisphosphonates in the 6 months prior to randomization; treatment with more than 1 cycle of intermittent oral bisphosphonates in the 6 months prior to randomization; or having received the last cycle of this intermittent oral regimen less than 4 weeks prior to screening.
- •patients receiving intravenous zoledronic acid during the 12 months prior to randomization.
- •vitamin D greater than 50,000 International Units (IU) per week or with any dose of calcitriol or vitamin D analogs or agonists in the 6 months prior to randomization.
- •systemic corticosteroids in the 1 month prior to randomization or for more than 30 days in the 1 year prior to randomization. (Ophthalmic, otic, topical, orally inhaled, nasally inhaled, or intra-articular corticosteroid therapy may be used without these restrictions.)
- •any other drug known to significantly affect bone metabolism in the 6 months prior to randomization.
- •warfarin or other coumadin anticoagulants in the 1 month prior to randomization.
- •any investigational drug in the 1 month prior to entry into the study.
研究组 & 干预措施
20 mcg Subcutaneous Teriparatide
Active Comparator
Received 20 micrograms (mcg) subcutaneously once daily in an unblinded manner.
干预措施: Subcutaneous Teriparatide (Drug)
30 mcg Transdermal Teriparatide
Experimental
Received 30 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
干预措施: Transdermal Teriparatide (Drug)
50 mcg Transdermal Teriparatide
Experimental
Received 50 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
干预措施: Transdermal Teriparatide (Drug)
80 mcg Transdermal Teriparatide
Experimental
Received 80 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
干预措施: Transdermal Teriparatide (Drug)
结局指标
主要结局
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months
时间窗: Baseline, 12 Months
Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model and least square (LS) means were adjusted for baseline BMD values as a covariate and pooled site and treatment as fixed effects.
次要结局
- Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)(Pre-Dose, 30 minutes, 2 hours Post-Dose at Baseline and 12 Months)
- Time Course Change of BMD Response at the Lumbar Spine(Baseline to 6 Months and 12 Months)
- Percent Change From Baseline of C-Terminal Telopeptide (CTX)(Baseline, 1 Month, 3 Months, 6 Months, 12 Months)
- Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours(Baseline, 12 Months)
- Pharmacokinetics Parameters: Area Under the Curve (AUC)(Baseline, 1 Month, 3 Months, and 12 Months)
- Pharmacokinetics Parameters: Maximal Concentration (Cmax)(Baseline, 1 Month, 3 Months, 12 Months)
- Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months(Baseline, 6 Months)
- Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP)(Baseline, 1 Month, 3 Months, 6 Months, 12 Months)
- Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month(Baseline, 1 Month)
- Convenience/Ease of Use Questionnaire (CEUQ)(baseline up to 12 months)
- Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels(Baseline and 1, 3, 12, and 13 Months (mon))
- DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up(13 Month follow-up)
- Change From Baseline in Urine Calcium Excretion at 6 and 12 Months(Baseline, 6 Months, 12 Months)
- Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon).(Pre-dose, 30 minutes, 2 hours at Baseline and 12 Months)
- DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up(13 Month follow-up)
研究者
研究点 (1)
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