## Protocol Section
### Identification Module
**NCT ID:** NCT02760979

**Brief Title:** The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty

**Official Title:** The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty: A Randomised, Double Blind, Placebo Controlled Clinical Trial

#### Organization Study ID Info
**ID:** IIBSP-DEN-2012-24
#### Organization
**Class:** OTHER
**Full Name:** Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
#### Secondary ID Infos
**ID:** 2012-001285-15
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2015-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-08-11

**Type:** ACTUAL

**Last Update Submit Date:** 2017-08-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-01

**Type:** ACTUAL

#### Start Date
**Date:** 2013-01

**Status Verified Date:** 2017-08

#### Study First Post Date
**Date:** 2016-05-04
**Type:** ESTIMATED
**Study First Submit Date:** 2016-04-28
**Study First Submit QC Date:** 2016-05-02
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study evaluates the effect of Denosumab in decreasing the periprosthetic bone resorption after Total Knee Arthroplasty compared to placebo in 60 patients (30 placebo and 30 Denosumab) within a year after surgery.

**Detailed Description:** Periprosthetic bone resorption after Total Knee Arthroplasty occurs as a consequence of prosthetic implant on the bone. Some of this patients (up to 13%) develop an aseptic failure of the prosthesis needing revision surgery.

2 groups of patients are treated with Placebo and Denosumab in a double blind prospective trial. Densitometry, Knee society score (KSS), Western Ontario McMaster University Osteoarthritis Index (WOMAC) and the Medical Outcomes Study Short Form 36 (SF-36) were done in both groups at 0,3,6 and 12 months after surgery.

### Conditions Module

**Conditions:**

- Bone Resorption

**Keywords:**

- knee arthroplasty

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 60

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients treated with Denosumab

**Intervention Names:**

- Drug: Denosumab

**Label:** Denosumab

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Patients treated with placebo

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Denosumab

**Description:** Denosumab treatment one year after surgery

**Name:** Denosumab

**Other Names:**

- Prolia

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Serum one year after surgery

**Name:** Placebo

**Other Names:**

- Serum

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Bone Mass index in gr/cm3

**Measure:** Change in Bone Mass index

**Time Frame:** Change in densitometry before surgery (0) and at three (3) months after surgery

**Description:** Bone Mass index in gr/cm3

**Measure:** Change in Bone Mass index

**Time Frame:** Change in densitometry before surgery (0) and at six (6) months after surgery

**Description:** Bone Mass index in gr/cm3

**Measure:** Change in Bone Mass index

**Time Frame:** Change in densitometry before surgery (0) and at twelve (12) months after surgery

#### Secondary Outcomes

**Measure:** Quality of Life (WOMAC)

**Time Frame:** WOMAC test before (0) and at three (3), six (6) and twelve (12) months after surgery

**Measure:** Quality of life (SF-36)

**Time Frame:** SF-36 test before (0) and at three (3), six (6) and twelve (12) months after surgery

**Description:** Creatinine clearance

**Measure:** Kidney function

**Time Frame:** Before surgery and at three, six and twelve months after surgery

**Description:** ALT, AST

**Measure:** Liver function

**Time Frame:** Before surgery and at three, six and twelve months after surgery

**Description:** Beta cross lap and Procollagen type 1 n-terminal propeptide (P1NP)

**Measure:** Bone turnover markers

**Time Frame:** At three, six and twelve months after surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with Knee Osteoarthritis treated with Total Knee Arthroplasty

Exclusion Criteria:

* Patients allergies to Denosumab
* Patients with previous Osteoporosis treatment
* Patients with renal failure
* Patients with previous Bisphosphonate treatment for more than 5 years

**Minimum Age:** 55 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Orthopaedic Department-Hospital de la Santa Creu i Sant Pau

**Name:** Jose Carlos Gonzalez

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Ishii Y, Yagisawa K, Ikezawa Y. Changes in bone mineral density of the proximal femur after total knee arthroplasty. J Arthroplasty. 2000 Jun;15(4):519-22. doi: 10.1054/arth.2000.4639.

**PMID:** 10884214

**Citation:** Sugita T, Umehara J, Sato K, Inoue H. Influence of tibial bone quality on loosening of the tibial component in total knee arthroplasty for rheumatoid arthritis: long-term results. Orthopedics. 1999 Feb;22(2):213-5. doi: 10.3928/0147-7447-19990201-10.

**PMID:** 10037335

**Citation:** Wang CJ, Wang JW, Weng LH, Hsu CC, Huang CC, Chen HS. The effect of alendronate on bone mineral density in the distal part of the femur and proximal part of the tibia after total knee arthroplasty. J Bone Joint Surg Am. 2003 Nov;85(11):2121-6. doi: 10.2106/00004623-200311000-00009.

**PMID:** 14630840

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5141

- Name: Bone Resorption

- Relevance: HIGH

- As Found: Bone Resorption

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001862

- Term: Bone Resorption

### 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: M417

- Name: Denosumab

- Relevance: HIGH

- As Found: 0.05

### Intervention Browse Module - Meshes

- ID: D000069448

- Term: Denosumab

### Misc Info Module

- Version Holder: 2024-05-24
