## Protocol Section
### Identification Module
**NCT ID:** NCT01267279

**Brief Title:** Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty

**Official Title:** Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty

#### Organization Study ID Info
**ID:** SJRC-Reclast
#### Organization
**Class:** OTHER
**Full Name:** Spokane Joint Replacement Center
### Status Module
#### Completion Date
**Date:** 2014-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-12-19

**Type:** ACTUAL

**Last Update Submit Date:** 2018-11-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-12

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2018-12-19

**Type:** ACTUAL

**Results First Submit Date:** 2018-10-17

**Results First Submit QC Date:** 2018-11-27

#### Start Date
**Date:** 2005-01

**Status Verified Date:** 2018-11

#### Study First Post Date
**Date:** 2010-12-28
**Type:** ESTIMATED
**Study First Submit Date:** 2010-12-24
**Study First Submit QC Date:** 2010-12-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Spokane Joint Replacement Center

#### Responsible Party

**Investigator Affiliation:** Spokane Joint Replacement Center

**Investigator Full Name:** David F. Scott, MD

**Investigator Title:** PI

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Osteoporosis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 51

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Drug: Zoledronic acid

**Label:** Zoledronic Acid

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Zoledronic Acid

**Description:** Zoledronic acid per protocol

**Name:** Zoledronic acid

**Other Names:**

- Reclast

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Placebo

**Name:** Placebo

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Bone Mineral Density (BMD)

**Time Frame:** 2 years post-operative

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001851

- Term: Bone Diseases, Metabolic

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12947

- Name: Osteoporosis

- Relevance: HIGH

- As Found: Osteoporosis

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5130

- Name: Bone Diseases, Metabolic

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010024

- Term: Osteoporosis

### Intervention Browse Module - Ancestors

- ID: D000050071

- Term: Bone Density Conservation Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M1699

- Name: Zoledronic Acid

- Relevance: HIGH

- As Found: Lymphoblastic

### Intervention Browse Module - Meshes

- ID: D000077211

- Term: Zoledronic Acid

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Placebo

**Deaths Num At Risk:** 24

**Description:** Placebo

**ID:** EG000

**Other Num at Risk:** 24

**Serious Number Affected:** 2

**Serious Number At Risk:** 24

**Title:** Placebo

**Group ID:** EG001

**Title:** Zoledronic Acid

**Deaths Num At Risk:** 27

**Description:** Zoledronic acid: Zoledronic acid per protocol

**ID:** EG001

**Other Num Affected:** 2

**Other Num at Risk:** 27

**Serious Number Affected:** 3

**Serious Number At Risk:** 27

**Title:** Zoledronic Acid

**Frequency Threshold:** 0

#### Other Events

**Term:** Flu-like symptoms

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

#### Serious Events

**Term:** hepatic liver mass

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 27

**Term:** THA revision

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 27

**Num Events:** 1

**Term:** Liver cancer

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 24

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 27

**Num Events:** 1

**Term:** Muscular atrophy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 24

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 27

**Num Events:** 1

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 24

**Group ID:** BG001

**Value:** 27

**Group ID:** BG002

**Value:** 51

**Units:** Participants

### Group

**ID:** BG000

**Title:** Placebo

**Description:** Placebo

### Group

**ID:** BG001

**Title:** Zoledronic Acid

**Description:** Zoledronic acid: Zoledronic acid per protocol

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 51

**Upper Limit:** 77

**Value:** 61.8

#### Measurement

**Group ID:** BG001

**Lower Limit:** 33

**Upper Limit:** 84

**Value:** 60.25

#### Measurement

**Group ID:** BG002

**Lower Limit:** 33

**Upper Limit:** 84

**Value:** 61.03

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 24

**Group ID:** BG001

**Value:** 27

**Group ID:** BG002

**Value:** 51

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 13

#### Measurement

**Group ID:** BG001

**Value:** 15

#### Measurement

**Group ID:** BG002

**Value:** 28

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 11

#### Measurement

**Group ID:** BG001

**Value:** 12

#### Measurement

**Group ID:** BG002

**Value:** 23

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 24

**Group ID:** BG001

**Value:** 27

**Group ID:** BG002

**Value:** 51

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 0

**Group ID:** BG001

**Value:** 0

**Group ID:** BG002

**Value:** 0

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 24

#### Measurement

**Group ID:** BG001

**Value:** 27

#### Measurement

**Group ID:** BG002

**Value:** 51

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 24

**Group ID:** BG001

**Value:** 27

**Group ID:** BG002

**Value:** 51

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** Years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Race and Ethnicity were not collected from any participant.
**Title:** Race and Ethnicity Not Collected
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** dfscott@mac.com
**Organization:** Spokane Joint Replacement Center
**Phone:** 509-466-6393
**Title:** Principal Investigator
## Results Section - Outcome Measures Module
### Outcome Measure 1
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 15.2
- **Upper Limit:** 
- **Value:** -3.97
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 9.8
- **Upper Limit:** 
- **Value:** 14.30
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 11.4
- **Upper Limit:** 
- **Value:** -27.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 12.4
- **Upper Limit:** 
- **Value:** -9.58
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 2 years post-operative
**Title:** Bone Mineral Density (BMD)
**Type:** PRIMARY
**Unit of Measure:** Percent change
##### Group
**Description:** Placebo
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Zoledronic acid: Zoledronic acid per protocol
**ID:** OG001
**Title:** Zoledronic Acid
### Participant Flow Module
#### Group
**Description:** Placebo
**ID:** FG000
**Title:** Placebo
#### Group
**Description:** Zoledronic acid: Zoledronic acid per protocol
**ID:** FG001
**Title:** Zoledronic Acid
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 24
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 27
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 22
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 21
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 6
**Has Results:** True