A Study to Evaluate the Efficacy, Pharmacodynamics, Safet... | NCT04934072

ID	Type	Description	Link
2020-004422-31	EudraCT Number

Status Module

Label	Type	Description	Intervention Names
FKS518	Experimental	FKS518 was administered on Day 1, and then every 26 weeks (6 months), i.e., Week 26 and Week 52, at a dose of 60 mg for a total of 3 administrations.	Drug: FKS518
US-Prolia	Active Comparator	US-Prolia was administered on Day 1, and then every 26 weeks (6 months), i.e., Week 26 and Week 52, at a dose of 60 mg for a total of 3 administrations.	Drug: US-licensed Prolia (Amgen)

Name	Type	Description	Arm Group Labels	Other Names
FKS518	Drug	subcutaneously by single-use prefilled syringe (PFS)	FKS518

Measure	Description	Time Frame
Percentage Change From Baseline in LS-BMD by DXA	Bone density was measured at the lumbar spine from L1 through L4. Per FDA request for this study, data were analyzed by non-inferiority and non-superiority analyses. Decreased BMD is associated with risk of fracture.	Baseline and Week 52

Measure	Description	Time Frame
Area Under the Effect Curve (AUEC) of Serum C-terminal Cross-linking Telopeptide of Type 1 Collagen (CTX)	Area under the effect curve for the (untransformed) biomarker concentrations from baseline up to Week 26. Any possible rebound effect where biomarker concentrations rose above baseline was not taken into account, and only the area below baseline was considered in this parameter.	Baseline to Week 26

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Female ≥55 to ≤85 years of age, inclusive, at screening.
Have a body mass index (BMI) ≥18 to ≤32 kg/m^2.
Participant should have confirmed postmenopausal status, defined as age-related or early/premature amenorrhea ≥12 consecutive months and increased follicle-stimulating hormone (FSH) >40 mIU/mL at screening; or surgical menopause (bilateral oophorectomy with or without hysterectomy) ≥12 months prior to screening.
Absolute bone mineral density (BMD) consistent with T-score ≤-2.5 and ≥-4.0 at the lumbar spine as measured by dual energy x-ray absorptiometry (DXA) as per central assessment.
At least 2 vertebrae in the lumbar vertebrae 1 to lumbar vertebrae 4 (L1-L4) region and at least 1 hip joint are evaluable by DXA.
Clinically acceptable physical examinations and laboratory tests and no history or evidence of any clinically significant concomitant medical disorder that, in the opinion of the Investigator, would pose a risk to participant safety or interfere with study evaluations or procedures.
Written informed consent including accepting a separate Information Sheet containing important information about COVID-19 and its general risks for participants participating in the clinical trial.

Exclusion Criteria:

Disease-related

History and/or presence of 1 severe or >2 moderate vertebral fractures or hip fracture confirmed by x-ray.
Presence of active healing fracture at screening.
History and/or presence of bone-related disorders, such as but not limited to Paget's disease, osteomalacia, hyperparathyroidism (or parathyroid disorders), or renal osteodystrophy.
Osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures (eg, tooth extraction, dental implants, or oral surgery in the past 6 months), poor oral hygiene, periodontal, and/or pre-existing dental disease as assessed by the Investigator.
Evidence of hypocalcemia (albumin-adjusted serum calcium <2.13 mmol/L or <8.5 mg/dL) or hypercalcemia (albumin-adjusted serum calcium >2.6 mmol/L or >10.5 mg/dL) as assessed by the central laboratory at screening.
Vitamin D deficiency (25-hydroxy vitamin D levels <12 ng/mL) as assessed by central laboratory at screening (retest is allowed once).
Known intolerance to calcium or vitamin D supplements.

Other Medical Conditions
Known or suspected clinically relevant drug hypersensitivity to any components of the study drug, comparable drugs, or to latex.
Renal impairment: creatinine clearance <30 mL/min at screening or receiving dialysis.
Medical evidence of current or history of primary or secondary immunodeficiency.
Infection-related exclusions as further defined in the protocol.
Major surgical procedure within 8 weeks prior to the screening or scheduled during the study.
Current or history of any malignancy, or myeloproliferative, or lymphoproliferative disease within 5 years before screening.
History of clinically significant drug or alcohol abuse within the last year prior to randomization.
Prior denosumab (Prolia, Xgeva, or proposed denosumab biosimilar) exposure.
Prior use of fluoride within the 5 years before inclusion in the study.
Any current or prior use of strontium ranelate.
Any current or prior use of intravenous bisphosphonates.
Current or prior use of teriparatide and other parathormone (PTH) analogues within 12 months before screening.
Current or prior use of systemic oral or transdermal estrogen or selective estrogen receptor modulators or tibolone within 6 months before screening.
Current or prior use of calcitonin or cinacalcet within 3 months before screening or any cathepsin K inhibitor (eg, odanacatib) within 18 months before screening.
Current or prior use of romosozumab or antisclerostin antibody.
Current or prior use of other osteoporotic agents used for the prevention or treatment of osteoporosis.
Current use within 3 months before screening of any medication with known influence on the skeletal system (eg, systemic corticosteroids, heparin, lithium, etc) with exceptions described in the protocol.
Concomitant treatment with another biologic drug.
Have received a COVID-19 vaccine within 4 weeks before randomization or COVID-19 vaccination is ongoing at the time of screening.

Facility	Status	City	State	ZIP	Country	Contacts
Diagnostic Consultative Center Aleksandrovska		Sofia	Sofia-Grad	1431	Bulgaria
Diagnostic Consultative Center (DCC) 17 - Sofia

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Core Treatment Period FKS518	Participants received FKS518 60 mg subcutaneously on Day 1 and Week 26 during the Core Treatment Period (Baseline to Week 52).
FG001	Core Treatment Period US-Prolia

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jan 17, 2023

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage Change From Baseline in LS-BMD by DXA

Bone density was measured at the lumbar spine from L1 through L4. Per FDA request for this study, data were analyzed by non-inferiority and non-superiority analyses. Decreased BMD is associated with risk of fracture.

ITT Analysis Set: The ITT Analysis Set included all randomized participants. Participants were analyzed according to their randomized treatment.

Posted

Least Squares Mean

Standard Error

Percentage change

Baseline and Week 52

ID	Title	Description
OG000	Core Treatment Period FKS518	Participants received FKS518 60 mg subcutaneously on Day 1 and Week 26 during the Core Treatment Period (Baseline to Week 52).
OG001	Core Treatment Period US-Prolia	Participants received US-Prolia 60 mg subcutaneously on Day 1 and Week 26 during the Core Treatment Period (Baseline to Week 52).

Units	Counts
Participants	OG000277 OG001276

Title

Denominators

Categories

Non-Inferiority Analysis

Title	Measurements
	OG0005.52± 0.292 OG0015.07± 0.297

Non-Superiority Analysis

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Mean Difference (Final Values)	0.46	Standard Error of the Mean	0.306	2-Sided	90	-0.05	0.96			Difference : FKS518 - US-Prolia		Non-Inferiority	Non-inferiority of FKS518 to US-Prolia was demonstrated if the 90% CI for the difference in mean percent change from baseline to Week 52 in LS-BMD laid entirely above -1.45%.

Secondary

Area Under the Effect Curve (AUEC) of Serum C-terminal Cross-linking Telopeptide of Type 1 Collagen (CTX)

Area under the effect curve for the (untransformed) biomarker concentrations from baseline up to Week 26. Any possible rebound effect where biomarker concentrations rose above baseline was not taken into account, and only the area below baseline was considered in this parameter.

ITT Analysis Set: The ITT Analysis Set included all randomized participants. Participants were analyzed according to their randomized treatment.

Posted

Geometric Least Squares Mean

95% Confidence Interval

(ng*h/L)

Baseline to Week 26

ID	Title	Description
OG000	FKS518	Participants received FKS518 60 mg subcutaneously on Day 1 and Week 26 during the Core Treatment Period (Baseline to Week 52).
OG001	US-Prolia	Participants received US-Prolia 60 mg subcutaneously on Day 1 and Week 26 during the Core Treatment Period (Baseline to Week 52).

Units	Counts
Participants

Secondary

Percentage Change From Baseline in BMD at Femoral Neck and Total Hip by DXA

The proximal femur (inclusive of femoral neck and total hip) DXA scans were obtained from the left side when possible. If the right side had to be used (e.g., due to implants) or was inadvertently used at baseline, then it had to be used consistently throughout the study. Data reported are for one half of the body only.

ITT Analysis Set: The ITT Analysis Set included all randomized participants. Participants were analyzed according to their randomized treatment.

Posted

Least Squares Mean

Standard Error

Percentage change

Baseline and Week 52

ID	Title	Description
OG000	Core Treatment Period FKS518	Participants received FKS518 60 mg subcutaneously on Day 1 and Week 26 during the Core Treatment Period (Baseline to Week 52).
OG001	Core Treatment Period US-Prolia	Participants received US-Prolia 60 mg subcutaneously on Day 1 and Week 26 during the Core Treatment Period (Baseline to Week 52).

Units	Counts
Participants

Secondary

Percentage Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)

P1NP is a bone biomarker. Serum samples were collected for analysis of P1NP to evaluate bone formation (P1NP) in response to treatment with FKS518 and US-Prolia. A decrease in the serum levels of P1NP is expected following treatment with denosumab and is suggestive of improvement.

Pharmacodynamic (PD) Analysis Set: All participants who received at least 1 dose of investigational product, had a quantifiable baseline PD marker concentration, and enough samples not impacted by protocol deviations to calculate the PD parameter. Only participants with available data are included.

Posted

Least Squares Mean

Standard Error

Percentage change

Baseline and Week 52 pre dose

ID	Title	Description
OG000	Core Treatment Period FKS518	Participants received FKS518 60 mg subcutaneously on Day 1 and Week 26 during the Core Treatment Period (Baseline to Week 52).
OG001	Core Treatment Period US-Prolia	Participants received US-Prolia 60 mg subcutaneously on Day 1 and Week 26 during the Core Treatment Period (Baseline to Week 52).

Units	Counts

Secondary

Percentage Change From Baseline in Serum C-terminal Cross-linking Telopeptide of Type 1 Collagen (CTX)

Serum CTX is a bone biomarker. Serum samples were collected for analysis of CTX to evaluate bone resorption in response to treatment with FKS518 or US-Prolia.

A decrease in the serum levels of CTX is expected following treatment with US-Prolia and is suggestive of improvement.

PD Analysis Set: All participants who received at least 1 dose of investigational product, had a quantifiable baseline PD marker concentration, and enough samples not impacted by protocol deviations to calculate the PD parameter. Only participants with available data are included.

Posted

Least Squares Mean

Standard Error

Percentage Change

Baseline and Week 52 pre dose

ID	Title	Description
OG000	Core Treatment Period FKS518	Participants received FKS518 60 mg subcutaneously on Day 1 and Week 26 during the Core Treatment Period (Baseline to Week 52).
OG001	Core Treatment Period US-Prolia	Participants received US-Prolia 60 mg subcutaneously on Day 1 and Week 26 during the Core Treatment Period (Baseline to Week 52).

Units	Counts

Secondary

Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)

Treatment-emergence was defined as AEs that began or increased in severity or frequency on or after the date of first administration of IP in a given treatment Period (Core or Transition) up to the Early Termination/End of Study Visit.

Safety Analysis Set (SAF): The SAF included all participants who received at least 1 dose of IP. The Transition Period Safety Analysis (TP-SAF) Set included all participants who received at least 1 dose of IP during the course of the TP. Participants were analyzed according to the actual treatment they received.

Posted

Count of Participants

Participants

Day 1 to Week 78

ID	Title	Description
OG000	Core Treatment Period FKS518	Participants received FKS518 60 mg subcutaneously on Day 1 and Week 26 during the Core Treatment Period (Baseline to Week 52).
OG001	Core Treatment Period US-Prolia	Participants received US-Prolia 60 mg subcutaneously on Day 1 and Week 26 during the Core Treatment Period (Baseline to Week 52).
OG002	Core Treatment Period: FKS518; Transition Period: FKS518	Participants treated with FKS518 during Core Treatment Period received FKS518 60 mg subcutaneously on Week 52 during the Transition Period (Week 52 to Week 78).

Secondary

Number of Participants Who Experienced a Treatment-Emergent Serious Adverse Event (TESAE)

Treatment-emergence was defined as SAEs that began or increased in severity or frequency on or after the date of first administration of IP up to the Early Termination/End of Study Visit.

SAF: SAF included all participants who received at least 1 dose of IP. The TP-SAF Set included all participants who received at least 1 dose of IP during the course of the TP. Participants were analyzed according to the actual treatment they received.

Posted

Count of Participants

Participants

Day 1 to Week 78

ID	Title	Description
OG000	Core Treatment Period FKS518	Participants received FKS518 60 mg subcutaneously on Day 1 and Week 26 during the Core Treatment Period (Baseline to Week 52).
OG001	Core Treatment Period US-Prolia	Participants received US-Prolia 60 mg subcutaneously on Day 1 and Week 26 during the Core Treatment Period (Baseline to Week 52).
OG002	Core Treatment Period: FKS518; Transition Period: FKS518	Participants treated with FKS518 during Core Treatment Period received FKS518 60 mg subcutaneously on Week 52 during the Transition Period (Week 52 to Week 78). This Reporting Group is used to report the results of the Transition period (Week 52 to 78).

Secondary

Number of Participants Who Experienced a Treatment-emergent Adverse Event of Special Interest (AESI)

A Treatment-emergent AESI is defined as drug-related hypersensitivity/allergic reactions (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≥3 or reported as serious adverse events [SAEs]) and AEs leading to IP discontinuation or study withdrawal.

Posted

Count of Participants

Participants

Day 1 to Week 78

ID	Title	Description
OG000	Core Treatment Period FKS518	Participants received FKS518 60 mg subcutaneously on Day 1 and Week 26 during the Core Treatment Period (Baseline to Week 52).
OG001	Core Treatment Period US-Prolia	Participants received US-Prolia 60 mg subcutaneously on Day 1 and Week 26 during the Core Treatment Period (Baseline to Week 52).
OG002	Core Treatment Period: FKS518; Transition Period: FKS518	Participants treated with FKS518 during Core Treatment Period received FKS518 60 mg subcutaneously on Week 52 during the Transition Period (Week 52 to Week 78). This Reporting Group is used to report the results of the Transition period (Week 52 to 78).

Secondary

Number of Participants Who Experienced an Injection Site Reaction (ISR)

Local tolerability in terms of ISRs was assessed by inspection of the skin and appendages in proximity to the site of administration. The injection site was the abdomen, and the IP was injected slowly. This local tolerability assessment was performed by the Investigator or designee to determine the presence of e.g., erythema, rash, tenderness, swelling, itching, bruising, pain, extravasation, phlebitis, or other types of reaction. The Investigator was also requested to ask participants during assessment about any such reactions that may have occurred since last assessment.

SAF: The SAF included all participants who received at least 1 dose of IP. The TP-SAF Set included all participants who received at least 1 dose of IP during the course of the TP. Participants were analyzed according to the actual treatment they received.

Posted

Count of Participants

Participants

Day 1 to Week 78

ID	Title	Description
OG000	Core Treatment Period FKS518	Participants received FKS518 60 mg subcutaneously on Day 1 and Week 26 during the Core Treatment Period (Baseline to Week 52).
OG001	Core Treatment Period US-Prolia	Participants received US-Prolia 60 mg subcutaneously on Day 1 and Week 26 during the Core Treatment Period (Baseline to Week 52).
OG002

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Core Treatment Period: FKS518	Participants received FKS518 60 mg subcutaneously on Day 1 and Week 26 during the Core Treatment Period (Baseline to Week 52).	277	43	277	69	277
EG001	Core Treatment Period: US-Prolia	Participants received US-Prolia 60 mg subcutaneously on Day 1 and Week 26 during the Core Treatment Period (Baseline to Week 52).	276	50	276	78	276
EG002	Transition Treatment Period: FKS518 (Was on FKS518 in CTP)	Participants treated with FKS518 during Core Treatment Period received FKS518 60 mg subcutaneously on Week 52 during the Transition Period (Week 52 to Week 78).	252	8	252	22	252
EG003	Transition Treatment Period: US-Prolia (Was on US-Prolia in CTP)	Participants treated with US-Prolia during Core period were continued to receive US-Prolia 60 mg subcutaneously on Week 52 during the Transition Period (Week 52 to Week 78).	125	6	125	15	125
EG004	Transition Treatment Period: FKS518 (Switched From US-Prolia in CTP)	Participants treated with US-Prolia during Core period were re-randomized to receive FKS518 60 mg subcutaneously on Week 52 during the Transition Period (Week 52 to Week 78).	124	6	124	24	124

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
COVID-19	Infections and infestations	MedDRA 24.0.	Systematic Assessment	EG00032 affected277 at risk EG00141 affected276 at risk EG0026 affected252 at risk EG0033 affected125 at risk EG0044 affected124 at risk
Asymptomatic COVID-19	Infections and infestations	MedDRA 24.0.	Systematic Assessment	EG0003 affected277 at risk EG0011 affected276 at risk EG0020 affected252 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA 24.0.	Systematic Assessment	EG0001 affected277 at risk EG0011 affected276 at risk EG0020 affected252 at risk EG003
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0.	Systematic Assessment	EG0000 affected277 at risk EG0010 affected276 at risk EG0020 affected252 at risk EG003
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0.	Systematic Assessment	EG0000 affected277 at risk EG0011 affected276 at risk EG0020 affected252 at risk EG003
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0.	Systematic Assessment	EG0001 affected277 at risk EG0010 affected276 at risk EG0020 affected252 at risk EG003
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0.	Systematic Assessment	EG0000 affected277 at risk EG0011 affected276 at risk EG0020 affected252 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0.	Systematic Assessment	EG0000 affected277 at risk EG0011 affected276 at risk EG0020 affected252 at risk EG003
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0.	Systematic Assessment	EG0000 affected277 at risk EG0011 affected276 at risk EG0020 affected252 at risk EG003
Nasopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0.	Systematic Assessment	EG0000 affected277 at risk EG0011 affected276 at risk EG0020 affected252 at risk EG003
Neuroendocrine tumour of the lung metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0.	Systematic Assessment	EG0000 affected277 at risk EG0011 affected276 at risk EG0020 affected252 at risk EG003
Oral papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0.	Systematic Assessment	EG0000 affected277 at risk EG0011 affected276 at risk EG0020 affected252 at risk EG003
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0.	Systematic Assessment	EG0000 affected277 at risk EG0011 affected276 at risk EG0020 affected252 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0.	Systematic Assessment	EG0001 affected277 at risk EG0010 affected276 at risk EG0020 affected252 at risk EG003
Balance disorder	Nervous system disorders	MedDRA 24.0.	Systematic Assessment	EG0001 affected277 at risk EG0011 affected276 at risk EG0020 affected252 at risk EG003
Chronic inflammatory demyelinating polyradiculoneuropathy	Nervous system disorders	MedDRA 24.0.	Systematic Assessment	EG0000 affected277 at risk EG0010 affected276 at risk EG0020 affected252 at risk EG003
Dizziness	Nervous system disorders	MedDRA 24.0.	Systematic Assessment	EG0000 affected277 at risk EG0010 affected276 at risk EG0020 affected252 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA 24.0.	Systematic Assessment	EG0001 affected277 at risk EG0010 affected276 at risk EG0020 affected252 at risk EG003
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 24.0.	Systematic Assessment	EG0001 affected277 at risk EG0010 affected276 at risk EG0020 affected252 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.0.	Systematic Assessment	EG0000 affected277 at risk EG0010 affected276 at risk EG0020 affected252 at risk EG003
Hydrometra	Reproductive system and breast disorders	MedDRA 24.0.	Systematic Assessment	EG0001 affected277 at risk EG0010 affected276 at risk EG0020 affected252 at risk EG003
Rectocele	Reproductive system and breast disorders	MedDRA 24.0.	Systematic Assessment	EG0001 affected277 at risk EG0010 affected276 at risk EG0020 affected252 at risk EG003
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 24.0.	Systematic Assessment	EG0000 affected277 at risk EG0010 affected276 at risk EG0021 affected252 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 24.0.	Systematic Assessment	EG0000 affected277 at risk EG0010 affected276 at risk EG0021 affected252 at risk EG003
Vestibular disorder	Ear and labyrinth disorders	MedDRA 24.0.	Systematic Assessment	EG0001 affected277 at risk EG0010 affected276 at risk EG0020 affected252 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 24.0.	Systematic Assessment	EG0000 affected277 at risk EG0010 affected276 at risk EG0020 affected252 at risk EG003
Device dislocation	Product Issues	MedDRA 24.0.	Systematic Assessment	EG0000 affected277 at risk EG0011 affected276 at risk EG0020 affected252 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0.	Systematic Assessment	EG0001 affected277 at risk EG0010 affected276 at risk EG0020 affected252 at risk EG003
Hypertension	Vascular disorders	MedDRA 24.0.	Systematic Assessment	EG0001 affected277 at risk EG0010 affected276 at risk EG0020 affected252 at risk EG003

ID	Term
D010024	Osteoporosis
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
C000729682	QL1206
D000069448	Denosumab

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	FKS518	FKS518: Participants received FKS518 60 mg subcutaneously on Day 1 and Week 26 during the Core Treatment Period (Baseline to Week 52).
BG001	US-Prolia	US-Prolia: Participants received US-Prolia 60 mg subcutaneously on Day 1 and Week 26 during the Core Treatment Period (Baseline to Week 52).
BG002	Total	Total of all reporting groups

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 24.0.	Systematic Assessment	EG00033 events26 affected277 at risk EG00141 events33 affected276 at risk EG00212 events11 affected252 at risk EG0038 events8 affected125 at risk EG00418 events17 affected124 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 24.0.	Systematic Assessment	EG00029 events23 affected277 at risk EG00136 events30 affected276 at risk EG00214 events12 affected252 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 24.0.	Systematic Assessment	EG00022 events18 affected277 at risk EG00128 events23 affected276 at risk EG0020 events0 affected252 at risk EG003
Headache	Nervous system disorders	MedDRA 24.0.	Systematic Assessment	EG00014 events13 affected277 at risk EG00115 events14 affected276 at risk EG0020 events0 affected252 at risk EG003