Osteoporosis
Conditions
Brief summary
In a randomized, double-blind trial, BMD of the operated proximal femur after total hip replacement measured by dual-energy x-ray absorptiometry (DXA) were compared for up to two years in patients receiving IV ZOL 5 mg infusion (n = 27) or placebo (IV saline infusion; n = 24) at two weeks and one year after surgery.
Interventions
DRUGZoledronic acid
Zoledronic acid per protocol
OTHERPlacebo
Placebo
Sponsors
Spokane Joint Replacement Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Patients undergoing primary elective total hip replacement
Exclusion criteria
* Osteoporosis (BMD ≤-2.5) * Trauma to the operated femur, hip revisions, femoral dysplasia, trochanteric osteotomy, inflammatory arthritis * Severe renal impairment * Use of any medications affecting BMD * Known sensitivity to bisphosphonates * Severe dental problems, and pregnancy or being able to conceive and not using reliable birth control methods
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone Mineral Density (BMD) | 2 years post-operative | Change in bone mineral density (BMD) (per dual energy x-ray absorptiometry (DXA) imaging) from 1 week post-operative data in the Standard and Custom Gruen Zones around the femoral stem. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo | 24 |
| Zoledronic Acid Zoledronic acid: Zoledronic acid per protocol | 27 |
| Total | 51 |
Baseline characteristics
| Characteristic | Zoledronic Acid | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 60.25 Years | 61.03 Years | 61.8 Years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 27 participants | 51 participants | 24 participants |
| Sex: Female, Male Female | 15 Participants | 28 Participants | 13 Participants |
| Sex: Female, Male Male | 12 Participants | 23 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 27 |
| other Total, other adverse events | 0 / 24 | 2 / 27 |
| serious Total, serious adverse events | 2 / 24 | 3 / 27 |
Outcome results
Primary
Bone Mineral Density (BMD)
Change in bone mineral density (BMD) (per dual energy x-ray absorptiometry (DXA) imaging) from 1 week post-operative data in the Standard and Custom Gruen Zones around the femoral stem.
Time frame: 2 years post-operative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Bone Mineral Density (BMD) | Gruen Zone 1: 2 years | -3.97 Percent change | Standard Deviation 15.2 |
| Placebo | Bone Mineral Density (BMD) | Gruen Zone 7: 2 years | -27.3 Percent change | Standard Deviation 11.4 |
| Zoledronic Acid | Bone Mineral Density (BMD) | Gruen Zone 1: 2 years | 14.30 Percent change | Standard Deviation 9.8 |
| Zoledronic Acid | Bone Mineral Density (BMD) | Gruen Zone 7: 2 years | -9.58 Percent change | Standard Deviation 12.4 |