Bisphosphonates for Prevention of Post-Denosumab Bone Loss
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|ClinicalTrials.gov Identifier: NCT03396315|
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : March 8, 2019
The primary goal of the study is to assess the extent to which bisphosphonate therapy will prevent decreases in bone mass that may occur after cessation of denosumab in premenopausal women with idiopathic osteoporosis (IOP) enrolled in AAAN0161 (FD05114) "Denosumab for the prevention of post-teriparatide bone loss in premenopausal women with idiopathic osteoporosis".
In addition, the investigator will observe participants for a second year off bisphosphonate therapy to assess duration of response.
The hypothesis is that bisphosphonate therapy with alendronate or zoledronic acid, initiated after recovery of bone remodeling activity, will prevent significant bone loss after discontinuing denosumab.
|Condition or disease||Intervention/treatment||Phase|
|IOP Osteoporosis||Drug: Alendronate Drug: Zoledronic Acid||Phase 2|
Osteoporosis in premenopausal women with normal menstrual function and no specific cause is termed idiopathic osteoporosis (IOP). IOP is a rare disease with an estimated prevalence of <200,000 affected premenopausal women in the United States.
Women with IOP completing at least one year and up to three years of denosumab (Protocol AAAN0161) will be offered participation in this open-label study in which they would choose whether to take oral alendronate 70 mg weekly for 12 months or a single intravenous dose of zoledronic acid 5 mg. Subjects and study personnel will be blinded to BMD outcomes until 12 months.
Discontinuation of denosumab is followed by substantial increases in bone turnover markers to well above baseline, bone resorption reaching twice baseline levels for about 6 months. Over the first 12 months off therapy, all the bone density gained on treatment is lost. Studies done at the institution has demonstrated the occurrence of multiple vertebral fractures in some patients who have stopped denosumab. Based upon these new fracture data, the Prolia label is currently recommending that consideration should be given to transition to another antiresorptive drug in patients stopping denosumab. The main goals of this extension study are to determine rates of bone loss and incidence of radiographic vertebral fractures during one year of bisphosphonate therapy (oral alendronate or intravenous zoledronic acid) initiated after completing denosumab.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||open-label study in which they would choose whether to take oral alendronate 70 mg weekly for 12 months or a single intravenous dose of zoledronic acid 5 mg.|
|Masking:||None (Open Label)|
|Official Title:||Bisphosphonates for Prevention of Post-Denosumab Bone Loss in Premenopausal Women With Idiopathic Osteoporosis|
|Actual Study Start Date :||January 29, 2018|
|Estimated Primary Completion Date :||January 1, 2023|
|Estimated Study Completion Date :||January 1, 2024|
Active Comparator: alendronate
Subjects will receive oral alendronate
oral alendronate 70 mg weekly for 12 months will be given for the prevention of osteoporosis
Other Name: fosamax
Active Comparator: zoledronic acid
Subjects will receive zoledronic acid
Drug: Zoledronic Acid
single intravenous dose of zoledronic acid 5 mg will be given for the prevention of osteoporosis
Other Name: Reclast
- Difference in BMD at the Lumbar spine (L1-4) within group [ Time Frame: Baseline, 12 month ]Within-group difference (percent change) in BMD at the lumbar spine (L1-4) will be measured by Dual-energy X-ray absorptiometry (DXA) and calculated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396315
|Contact: Mariana Bucovsky, BAemail@example.com|
|United States, Nebraska|
|Creighton University||Not yet recruiting|
|Omaha, Nebraska, United States, 68131|
|Principal Investigator: Robert Recker, MD|
|Sub-Investigator: Joan Lappe, MD|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Mariana Bucovsky, BA 212-305-7225|
|Principal Investigator: Elizabeth Shane, MD|
|Sub-Investigator: Adi Cohen, MD|
|Principal Investigator:||Elizabeth Shane, MD||Columbia University|